Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04858802
Status:
COMPLETED
Last Update Posted:
2023-04-21
First Post:
2021-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Clinical Evaluation of PROPEL® Contour Sinus Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Xiaomin.deng@medtronic.com', 'phone': '707-566-1311', 'title': 'Xiaomin Deng', 'organization': 'Medtronic plc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Per study eligibility criteria, participants were required to have a Lund-Mackay score ≥1 on both frontal sinus sides at baseline as assessed by clinical investigators. Only roughly half of participants met this criteria per independent, blinded review. This may confound results, as a Lund-Mackay score of ≥1 indicates CT evidence of sinonasal inflammation and is recommended as a precondition for surgery in the International Consensus Statement on Allergy and Rhinology: Rhinosinusitis 2021.'}}, 'adverseEventsModule': {'timeFrame': 'From enrollment through Day 180 (end of study)', 'description': 'A standard questionnaire was used to determine whether or not adverse events (AE) had occurred at the current follow-up visit or since the previous follow-up visit. Clinical investigators evaluated the occurrence of AEs excluding usual post-operative recovery signs and symptoms experienced by participants, unless corroborated by objective findings and/or requiring specific medical or therapeutic interventions.', 'eventGroups': [{'id': 'EG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'All sinuses exposed to the PROPEL Contour Sinus Implant', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 15, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'All sinuses that were not exposed to the PROPEL Contour Sinus Implant.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 16, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Chronic sinusitis', 'notes': 'Number affected reflects number of participants with at least once instance of the adverse event localized to either the treatment or control side.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'notes': 'Number affected reflects number of participants with at least once instance of the adverse event. COVID-19 cannot be localized to a side, so each instance is represented in both arms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Loss of balance', 'notes': 'Participant reported losing his balance while moving machinery down a ramp, resulting in a fall and bruising to his ribs, knee, and lower back. Loss of balance cannot be localized to a side, so each instance is represented in both arms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in FSO Patency by Blinded Reviewer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'categories': [{'measurements': [{'value': '16.54', 'spread': '20.83', 'groupId': 'OG000'}, {'value': '12.36', 'spread': '16.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.19', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '8.6', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.08', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area', 'groupDescription': 'The null hypothesis was that there would no difference in FSO cross-sectional area between treatment and control sides at Day 45.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 45', 'description': 'Side-to-side difference in frontal sinus ostium (FSO) patency at Day 45 based on cross-sectional area of FSO by computed tomography (CT) measurements performed by an independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants with data evaluable.'}, {'type': 'SECONDARY', 'title': 'FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Change from baseline to Day 45', 'categories': [{'measurements': [{'value': '2.63', 'spread': '9.95', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '11.09', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to Day 180', 'categories': [{'measurements': [{'value': '3.20', 'spread': '10.97', 'groupId': 'OG000'}, {'value': '5.95', 'spread': '13.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.328', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '4.5', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.98', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.063', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.75', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '0.2', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.64', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 45, and Day 180', 'description': 'FSO cross-sectional area change from baseline to Day 45 and change from baseline to Day 180 per CT assessment performed by an independent, blinded reviewer. FSO cross-sectional area was measured via computer-assisted segmentation of CT images.', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.'}, {'type': 'SECONDARY', 'title': 'CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '383.11', 'spread': '437.19', 'groupId': 'OG000'}, {'value': '332.17', 'spread': '399.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '386.86', 'spread': '413.56', 'groupId': 'OG000'}, {'value': '414.30', 'spread': '427.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.306', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.94', 'ciLowerLimit': '-47.5', 'ciUpperLimit': '149.4', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '430.80', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.567', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.44', 'ciLowerLimit': '-122.5', 'ciUpperLimit': '67.6', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '413.22', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired; the threshold for statistical significance was p = 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Days 45 and 180', 'description': 'FSOT, referring to the region of the frontal sinus surrounding the FSO, bordered superiorly by the frontal infundibulum and inferiorly by the frontal recess, is assessed by blinded reviewer. FSOT volume was measured via computer-assisted segmentation of CT images.', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.'}, {'type': 'SECONDARY', 'title': 'CT FSO Minimum Diameter by Blinded Reviewer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.38', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '1.79', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.56', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '2.54', 'spread': '2.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.9', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.92', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.943', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.27', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Days 45 and 180', 'description': 'CT FSO minimum diameter assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. FSO minimum diameter was measured via computer-assisted segmentation of CT images.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.'}, {'type': 'SECONDARY', 'title': "CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer", 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Day 45', 'categories': [{'measurements': [{'value': '1.23', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'categories': [{'measurements': [{'value': '1.22', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.715', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.24', 'estimateComment': "Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus", 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.129', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.96', 'estimateComment': "Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus", 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Days 45 and 180', 'description': "CT Zinreich's modified Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.\n\nZinreich's modified Lund-Mackay scale ranges from 0 to 5. Higher scores indicate a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Day 21', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 45', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.28', 'ciUpperLimit': '3.60', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'groupDescription': 'Day 21', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.453', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.73', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.219', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.61', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'groupDescription': 'Day 90', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.289', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.61', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Days 21, 45, 90 and 180', 'description': 'Need for post-operative intervention as determined by clinical investigators per endoscopy.', 'unitOfMeasure': 'sinus sides', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.'}, {'type': 'SECONDARY', 'title': 'CT Cross-sectional Area of FSO by Blinded Reviewer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'categories': [{'measurements': [{'value': '17.72', 'spread': '21.05', 'groupId': 'OG000'}, {'value': '17.81', 'spread': '19.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.971', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '4.8', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '21.12', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 180', 'description': 'CT cross-sectional area of FSO assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides'}, {'type': 'SECONDARY', 'title': 'CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Day 45', 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.1', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.56', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45'}, {'pValue': '0.288', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.1', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.42', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 180', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Days 45 and 180', 'description': 'CT Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.\n\nThe Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides'}, {'type': 'SECONDARY', 'title': 'CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.225', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.1', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.64', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.388', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.1', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.65', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone modified Lund-Mackay score for the frontal sinus at Day 180', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Days 45 and 180', 'description': 'CT Lund-Mackay for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.\n\nThe Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.'}, {'type': 'SECONDARY', 'title': 'Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.537', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.1', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.68', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO', 'groupDescription': 'Day 21', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.0', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.54', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '-0.1', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.70', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO', 'groupDescription': 'Day 90', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '-0.1', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.66', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Days 21, 45, 90 and 180', 'description': 'Endoscopic grading of adhesion/scarring grade in the frontal recess/FSO by clinical investigators.\n\nThe adhesion/scarring grade in the frontal recess/FSO scale ranges from 0 to 4. Higher scores indicate a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.'}, {'type': 'SECONDARY', 'title': 'Inflammation Score in the Frontal Recess/FSO by Clinical Investigators', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.94', 'spread': '29.31', 'groupId': 'OG000'}, {'value': '28.85', 'spread': '30.86', 'groupId': 'OG001'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.17', 'spread': '27.68', 'groupId': 'OG000'}, {'value': '26.67', 'spread': '32.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.97', 'spread': '34.10', 'groupId': 'OG000'}, {'value': '28.62', 'spread': '33.80', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.30', 'spread': '31.45', 'groupId': 'OG000'}, {'value': '24.46', 'spread': '33.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.634', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.46', 'ciLowerLimit': '-12.8', 'ciUpperLimit': '7.9', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '35.55', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO', 'groupDescription': 'Day 21', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.63', 'ciLowerLimit': '-15.2', 'ciUpperLimit': '-0.1', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.04', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.78', 'ciLowerLimit': '-14.7', 'ciUpperLimit': '-0.9', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '28.79', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO', 'groupDescription': 'Day 90', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.76', 'ciLowerLimit': '-13.2', 'ciUpperLimit': '-0.3', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '27.99', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Days 21, 45, 90 and 180', 'description': 'Endoscopic grading of inflammation score in the frontal recess/FSO by clinical investigators.\n\nInflammation score in the frontal recess/FSO ranges from 0 to 100. 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the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.48', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score', 'groupDescription': 'Day 21', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.823', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.7', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.30', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.26', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score', 'groupDescription': 'Day 90', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.188', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.2', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.16', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Days 21, 45, 90 and 180', 'description': 'Subject-reported outcome of chronic rhinosinusitis (CRS) side-specific symptom score.\n\nThe chronic rhinosinusitis side-specific symptom score scale ranges from 0 to 30. Higher scores indicate a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.'}, {'type': 'SECONDARY', 'title': 'SNOT-22 Score by Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'categories': [{'measurements': [{'value': '17.84', 'spread': '17.62', 'groupId': 'OG000'}, {'value': '17.84', 'spread': '17.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 180', 'description': 'Subject-reported outcome of SNOT-22 score.\n\nThe Sino-Nasal Outcome Test, 22 item (SNOT-22) is a validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a 6-point scale, ranging from a score of 0 ("no problem") to 5 ("problem as bad as it can be"). The maximum total score for all symptoms is equal to 110.\n\nHigher scores indicate a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants with data evaluable.'}, {'type': 'SECONDARY', 'title': 'RSI Score by Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '7.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 180', 'description': 'Subject-reported outcome of RSI score.\n\nThe Rhinosinusitis Symptom Inventory (RSI) scale ranges from 0 to 60. Higher scores indicate a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants with data evaluable.'}, {'type': 'SECONDARY', 'title': 'Implant Delivery Success by Clinical Investigators', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': "Number of subjects who underwent successful access and deployment of the PROPEL Contour Sinus Implant into the FSO. Delivery is considered successful if the procedure concludes with correct implant placement on the intended side, even if a second attempt to place the implant is necessary. An attempted deployment occurs when the investigator introduces the delivery system into the subject's nostril with the intent of placing an implant.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': "Difference in FSO Patency at Day 45 - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup", 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'categories': [{'measurements': [{'value': '14.98', 'spread': '18.21', 'groupId': 'OG000'}, {'value': '8.70', 'spread': '12.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.28', 'ciLowerLimit': '0.8', 'ciUpperLimit': '11.7', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '18.12', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 45', 'description': "Side-to-side difference in FSO patency at Day 45 based on cross-sectional area of FSO by CT measurements performed by an independent, blinded reviewer, as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer.", 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable.'}, {'type': 'POST_HOC', 'title': "FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup", 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Change from baseline to Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.87', 'spread': '9.59', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '10.87', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.29', 'spread': '12.46', 'groupId': 'OG000'}, {'value': '7.74', 'spread': '16.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.98', 'ciLowerLimit': '0.2', 'ciUpperLimit': '7.8', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.49', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.45', 'ciLowerLimit': '-7.5', 'ciUpperLimit': '0.6', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '13.02', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 45, and Day 180', 'description': "FSO cross-sectional area change from baseline to Day 45 and change from baseline to Day 180 per CT assessment performed by an independent, blinded reviewer, as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.", 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint.'}, {'type': 'POST_HOC', 'title': "CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup", 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '306.06', 'spread': '389.90', 'groupId': 'OG000'}, {'value': '244.52', 'spread': '394.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '282.89', 'spread': '394.99', 'groupId': 'OG000'}, {'value': '334.86', 'spread': '451.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.375', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '61.54', 'ciLowerLimit': '-76.7', 'ciUpperLimit': '199.8', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '460.18', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.432', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-51.98', 'ciLowerLimit': '-184.1', 'ciUpperLimit': '80.2', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '434.64', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Days 45 and 180', 'description': "FSOT, referring to the region of the frontal sinus surrounding the FSO, bordered superiorly by the frontal infundibulum and inferiorly by the frontal recess, as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer. FSOT volume was measured via computer-assisted segmentation of CT images.", 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint.'}, {'type': 'POST_HOC', 'title': "CT FSO Minimum Diameter by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup", 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'OG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'classes': [{'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.31', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'sinus sides', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.18', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '2.33', 'spread': '2.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.1', 'ciUpperLimit': '1.4', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.13', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter', 'groupDescription': 'Day 45', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.646', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.5', 'pValueComment': 'Paired; the threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.24', 'estimateComment': 'Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter', 'groupDescription': 'Day 180', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Days 45 and 180', 'description': "CT FSO minimum diameter as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer. FSO minimum diameter was measured via computer-assisted segmentation of CT images.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sinus sides', 'denomUnitsSelected': 'sinus sides', 'populationDescription': 'Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}, {'id': 'FG001', 'title': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.\n\nBalloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '80', 'numSubjects': '80'}, {'groupId': 'FG001', 'numUnits': '80', 'numSubjects': '80'}]}, {'type': 'Completed Day 45 Follow-up Visit', 'achievements': [{'groupId': 'FG000', 'numUnits': '80', 'numSubjects': '80'}, {'groupId': 'FG001', 'numUnits': '80', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '78', 'numSubjects': '78'}, {'groupId': 'FG001', 'numUnits': '78', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '2'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'sinus sides', 'recruitmentDetails': 'Participants were recruited from fourteen locations in the United States.', 'preAssignmentDetails': 'A total of 89 patients were assessed for eligibility. Eight patients did not meet inclusion criteria or met exclusion criteria. One patient withdrew from the study prior to randomization. A total of 80 patients met final eligibility and were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the frontal sinus ostium occurred on the randomized side. The opposing side served as control.\n\nPROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'spread': '13.38', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of prior endoscopic sinus surgeries (ESS)', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '≥ 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Asthma diagnosed by physician', 'classes': [{'title': 'Yes, any severity', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Yes, mild', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Yes, moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Yes, severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Asthma severity was assessed as either mild, moderate, or severe by clinical investigator.', 'unitOfMeasure': 'participants'}, {'title': 'Allergic rhinitis diagnosed by physician', 'classes': [{'title': 'Yes, any severity', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}, {'title': 'Yes, mild', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}, {'title': 'Yes, moderate', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Yes, severe', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Allergic rhinitis severity was assessed as either mild, moderate, or severe by clinical investigator.', 'unitOfMeasure': 'participants'}, {'title': 'Aspirin intolerance or allergy', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lund-Mackay score', 'classes': [{'title': 'Total score (left + right)', 'categories': [{'measurements': [{'value': '9.21', 'spread': '3.83', 'groupId': 'BG000'}]}]}, {'title': 'Frontal sinus score (left + right)', 'categories': [{'measurements': [{'value': '2.19', 'spread': '0.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Lund-Mackay scale is used as a staging system for chronic rhinosinusitis. A score is assigned by the grader based on the opacification of anatomical regions of the paranasal sinuses as visualized on CT imaging. The grader assigns a value of 0 if the region is totally patent, 1 if it is partially opacified, or 2 if it is completely opacified. The regions evaluated are the frontal, anterior ethmoid, posterior ethmoid, maxillary, and sphenoid sinuses. The ostiomeatal complex (OMC) is scored either 0 or 2. The maximum score for each side is thus 12, with a total score determined out of 24.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-26', 'size': 1540626, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-07T14:35', 'hasProtocol': True}, {'date': '2022-05-26', 'size': 319620, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-07T14:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intrapatient control in which eligible subjects will receive the PROPEL Contour Sinus Implant (Treatment) on one side, and no implant (Control) on the contralateral side.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2021-04-21', 'resultsFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-31', 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in FSO Patency by Blinded Reviewer', 'timeFrame': 'Day 45', 'description': 'Side-to-side difference in frontal sinus ostium (FSO) patency at Day 45 based on cross-sectional area of FSO by computed tomography (CT) measurements performed by an independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.'}], 'secondaryOutcomes': [{'measure': 'FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer', 'timeFrame': 'Baseline, Day 45, and Day 180', 'description': 'FSO cross-sectional area change from baseline to Day 45 and change from baseline to Day 180 per CT assessment performed by an independent, blinded reviewer. FSO cross-sectional area was measured via computer-assisted segmentation of CT images.'}, {'measure': 'CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer', 'timeFrame': 'Days 45 and 180', 'description': 'FSOT, referring to the region of the frontal sinus surrounding the FSO, bordered superiorly by the frontal infundibulum and inferiorly by the frontal recess, is assessed by blinded reviewer. FSOT volume was measured via computer-assisted segmentation of CT images.'}, {'measure': 'CT FSO Minimum Diameter by Blinded Reviewer', 'timeFrame': 'Days 45 and 180', 'description': 'CT FSO minimum diameter assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. FSO minimum diameter was measured via computer-assisted segmentation of CT images.'}, {'measure': "CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer", 'timeFrame': 'Days 45 and 180', 'description': "CT Zinreich's modified Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.\n\nZinreich's modified Lund-Mackay scale ranges from 0 to 5. Higher scores indicate a worse outcome."}, {'measure': 'Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators', 'timeFrame': 'Days 21, 45, 90 and 180', 'description': 'Need for post-operative intervention as determined by clinical investigators per endoscopy.'}, {'measure': 'CT Cross-sectional Area of FSO by Blinded Reviewer', 'timeFrame': 'Day 180', 'description': 'CT cross-sectional area of FSO assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.'}, {'measure': 'CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer', 'timeFrame': 'Days 45 and 180', 'description': 'CT Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.\n\nThe Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.'}, {'measure': 'CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators', 'timeFrame': 'Days 45 and 180', 'description': 'CT Lund-Mackay for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.\n\nThe Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.'}, {'measure': 'Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators', 'timeFrame': 'Days 21, 45, 90 and 180', 'description': 'Endoscopic grading of adhesion/scarring grade in the frontal recess/FSO by clinical investigators.\n\nThe adhesion/scarring grade in the frontal recess/FSO scale ranges from 0 to 4. Higher scores indicate a worse outcome.'}, {'measure': 'Inflammation Score in the Frontal Recess/FSO by Clinical Investigators', 'timeFrame': 'Days 21, 45, 90 and 180', 'description': 'Endoscopic grading of inflammation score in the frontal recess/FSO by clinical investigators.\n\nInflammation score in the frontal recess/FSO ranges from 0 to 100. Higher scores indicate a worse outcome.'}, {'measure': 'Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators', 'timeFrame': 'Days 21, 45, 90 and 180', 'description': 'Endoscopic grading of polypoid edema in the frontal recess/FSO by clinical investigators.\n\nPolypoid edema in the frontal recess/FSO scale ranges from 0 to 3. Higher scores indicate a worse outcome.'}, {'measure': 'Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators', 'timeFrame': 'Day 21, 45, 90, and 180', 'description': 'Endoscopic grading of adhesion/scarring grade in the ethmoid sinus by clinical investigators.\n\nThe adhesion/scarring grade in the ethmoid sinus scale ranges from 0 to 4. Higher scores indicate a worse outcome.'}, {'measure': 'Polyp Grade in the Ethmoid Sinus by Clinical Investigators', 'timeFrame': 'Days 21, 45, 90 and 180', 'description': 'Endoscopic grading of polyp grade in the ethmoid sinus by clinical investigators.\n\nPolyp grade in the ethmoid sinus scale ranges from 0 to 3. Higher scores indicate a worse outcome.'}, {'measure': 'CRS Side-specific Symptom Score by Subject', 'timeFrame': 'Days 21, 45, 90 and 180', 'description': 'Subject-reported outcome of chronic rhinosinusitis (CRS) side-specific symptom score.\n\nThe chronic rhinosinusitis side-specific symptom score scale ranges from 0 to 30. Higher scores indicate a worse outcome.'}, {'measure': 'SNOT-22 Score by Subject', 'timeFrame': 'Day 180', 'description': 'Subject-reported outcome of SNOT-22 score.\n\nThe Sino-Nasal Outcome Test, 22 item (SNOT-22) is a validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a 6-point scale, ranging from a score of 0 ("no problem") to 5 ("problem as bad as it can be"). The maximum total score for all symptoms is equal to 110.\n\nHigher scores indicate a worse outcome.'}, {'measure': 'RSI Score by Subject', 'timeFrame': 'Day 180', 'description': 'Subject-reported outcome of RSI score.\n\nThe Rhinosinusitis Symptom Inventory (RSI) scale ranges from 0 to 60. Higher scores indicate a worse outcome.'}, {'measure': 'Implant Delivery Success by Clinical Investigators', 'timeFrame': 'Baseline', 'description': "Number of subjects who underwent successful access and deployment of the PROPEL Contour Sinus Implant into the FSO. Delivery is considered successful if the procedure concludes with correct implant placement on the intended side, even if a second attempt to place the implant is necessary. An attempted deployment occurs when the investigator introduces the delivery system into the subject's nostril with the intent of placing an implant."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Frontal Sinus', 'Balloon Dilation'], 'conditions': ['Chronic Rhinosinusitis (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)', 'detailedDescription': 'A post-market, randomized, intra-patient controlled, blinded multicenter study with 80 randomized subjects at up to 20 study centers.\n\nAfter successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSure™ Nav Balloon Device and Fiagon Cube Navigation System, patients will be randomized to receive one PROPEL Contour Sinus Implant on one side while the contralateral side serves as the control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is 18 years of age or older.\n2. Patient is willing and able to comply with protocol requirements.\n3. Patient has confirmed diagnosis of CRS per International Consensus Statement on Allergy and Rhinology, Rhinosinusitis 2021 (ICAR:RS) guidelines.\n4. Bilateral disease in the frontal sinuses (Lund-Mackay CT score of ≥1 on each side) on CT scan within 90 days prior to the baseline.\n5. A successfully completed in-office bilateral balloon dilation of the FSO with no complication on either side that, in the opinion of the clinical investigator is amenable for PROPEL Contour Sinus Implant placement in both FSO\n\nExclusion Criteria:\n\n1. Patient has structural obstruction that precludes endoscopic visualization of one or both FSOs prior to implant placement.\n2. Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade \\> 2) unless reduced 30 days prior to the baseline procedure\n3. Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.\n4. Known history of allergy or intolerance to corticosteroids or mometasone furoate.\n5. Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers.\n6. Patients with electronic devices in direct connection to the brain or the nervous system such as implantable neurostimulators (e.g. deep brain stimulation), programmable cerebrospinal fluid (CSF) shunts.\n7. Patients with monopolar pacemakers (older designs, with lower resistance to interference) or ICD's (implantable cardioverter defibrillator).\n8. Patients with implantable, body worn devices such as insulin pumps.\n9. Evidence of purulence coming from paranasal sinuses or ostiomeatal complex.\n10. Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue).\n11. Active viral illness (e.g., flu, shingles).\n12. Use of parenteral or injected steroids (e.g. Kenalog) 30 days prior to the baseline procedure.\n13. Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to baseline procedure."}, 'identificationModule': {'nctId': 'NCT04858802', 'acronym': 'EXPAND', 'briefTitle': 'A Clinical Evaluation of PROPEL® Contour Sinus Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intersect ENT'}, 'officialTitle': 'The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Sinus Implant Placement in the Frontal Sinus Ostium Following In-office Bilateral Balloon Dilation', 'orgStudyIdInfo': {'id': 'P500-1220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PROPEL Contour Sinus Implant', 'description': 'Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.', 'interventionNames': ['Device: PROPEL Contour Sinus Implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Balloon Sinus Dilation Alone', 'description': 'Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.', 'interventionNames': ['Procedure: Balloon Sinus Dilation Alone']}], 'interventions': [{'name': 'PROPEL Contour Sinus Implant', 'type': 'DEVICE', 'description': '370 mcg mometasone furoate-coated sinus implant', 'armGroupLabels': ['PROPEL Contour Sinus Implant']}, {'name': 'Balloon Sinus Dilation Alone', 'type': 'PROCEDURE', 'description': 'No PROPEL Contour Sinus Implant', 'armGroupLabels': ['Balloon Sinus Dilation Alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sacramento ENT/DaVinci Research, LLC', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94108', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Otolaryngology', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT & Allergy Associate of Florida, LLC', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33426', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT & Allergy Associate of Florida, LLC', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'ENT of Georgia', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '66211', 'city': 'Leawood', 'state': 'Kansas', 'country': 'United States', 'facility': 'Ascentist Physicians Group', 'geoPoint': {'lat': 38.96667, 'lon': -94.6169}}, {'zip': '40205', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentuckiana Ear, Nose & Throat PSC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40220', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Advanced ENT & Allergy', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Madison ENT', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sinus Institute', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '76109', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Fort Worth ENT & Sinus', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '75034', 'city': 'Frisco', 'state': 'Texas', 'country': 'United States', 'facility': 'Collin County ENT', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}, {'zip': '75070', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'ENT Associates of Texas', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Alamo ENT Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intersect ENT', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}