Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-08 @ 11:19 AM
Study NCT ID:
NCT02228720
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2014-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jstambaugh@intersectent.com', 'phone': '6506412103', 'title': 'James Stambaugh', 'organization': 'Intersect ENT'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Day 90', 'eventGroups': [{'id': 'EG000', 'title': 'Propel Nova Sinus Implant', 'description': 'Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time', 'otherNumAtRisk': 15, 'otherNumAffected': 9, 'seriousNumAtRisk': 15, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Drainage, green', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Crusting in nares', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Device Placement Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Propel Nova Sinus Implant', 'description': 'Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time'}], 'classes': [{'title': 'Frontal Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Maxillary Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Procedure', 'description': 'Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.', 'unitOfMeasure': 'Percentage of attempted sinuses', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sinuses', 'denomUnitsSelected': 'Sinuses', 'populationDescription': 'Attempted frontal and maxillary sinus ostia'}, {'type': 'SECONDARY', 'title': 'Ostial Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Propel Nova Sinus Implant', 'description': 'Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time'}], 'classes': [{'title': 'Baseline - Frontal Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 30 - Frontal Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Day 90 - Frontal Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}]}]}, {'title': 'Baseline - Maxillary Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 30 - Maxillary Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Day 90 - Maxillary Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 30, Day 90', 'description': 'Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)', 'unitOfMeasure': 'percentage of evaluable sinuses', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sinuses', 'denomUnitsSelected': 'Sinuses', 'populationDescription': 'Frontal and maxillary sinus ostia'}, {'type': 'SECONDARY', 'title': 'Adhesion/Scarring Grade 2 & 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Propel Nova Sinus Implant', 'description': 'Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time'}], 'classes': [{'title': 'Baseline - Frontal Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 30 - Frontal Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'Day 90 - Frontal Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Baseline - Maxillary Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 30 - Maxillary Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 90 - Maxillary Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 30, Day 90', 'description': 'Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)', 'unitOfMeasure': 'percentage of evaluable sinuses', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sinuses', 'denomUnitsSelected': 'Sinuses', 'populationDescription': 'Frontal and maxillary sinus ostia'}, {'type': 'SECONDARY', 'title': 'Degree of Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Propel Nova Sinus Implant', 'description': 'Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time'}], 'classes': [{'title': 'Baseline - Frontal Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.8', 'spread': '23.14', 'groupId': 'OG000'}]}]}, {'title': 'Day 30 - Frontal Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.1', 'spread': '23.24', 'groupId': 'OG000'}]}]}, {'title': 'Day 90 - Frontal Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '25.23', 'groupId': 'OG000'}]}]}, {'title': 'Baseline - Maxillary Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.6', 'spread': '24.94', 'groupId': 'OG000'}]}]}, {'title': 'Day 30 - Maxillary Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.2', 'spread': '13.55', 'groupId': 'OG000'}]}]}, {'title': 'Day 90 - Maxillary Sinuses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.1', 'spread': '21.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 30, Day 90', 'description': 'Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sinuses', 'denomUnitsSelected': 'Sinuses', 'populationDescription': 'Frontal and maxillary sinus ostia'}, {'type': 'SECONDARY', 'title': 'Sino-Nasal Outcome Test (SNOT) 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Propel Nova Sinus Implant', 'description': 'Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.6', 'spread': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.5', 'spread': '19.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.6', 'spread': '19.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 30, Day 90', 'description': 'Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult patients (≥ 18 years of age) diagnosed with chronic sinusitis with or without nasal/sinus polyposis who are candidates for endoscopic sinus surgery and in whom placement of the Propel Nova Sinus Implant is both feasible and medically appropriate'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Propel Nova Sinus Implant', 'description': 'Sinus stent with steroid coating (370 ug mometasone furoate)\n\nPropel Nova Sinus Implant: Sinus stent with steroid coating (370 ug mometasone furoate)'}], 'periods': [{'title': 'Open Label - Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Open Label - Day 30', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Open Label - Day 90', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Propel Nova Sinus Implant', 'description': 'Steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'spread': '13.24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lund-Mackay Score (CT scan)', 'classes': [{'title': 'Frontal Sinuses', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.19', 'groupId': 'BG000'}]}]}, {'title': 'Maxillary Sinuses', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The severity of sinus mucosal inflammation or fluid accumulation scored as 0 (complete lucency), 1 (partial lucency) or 2 (complete opacity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All patients and sinuses in whom placement of a Propel Nova Sinus Implant was attempted.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Propel Nova Sinus Implant'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2014-06-25', 'resultsFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-25', 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device Placement Success Rate', 'timeFrame': 'Baseline Procedure', 'description': 'Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.'}], 'secondaryOutcomes': [{'measure': 'Ostial Patency', 'timeFrame': 'Baseline, Day 30, Day 90', 'description': 'Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)'}, {'measure': 'Adhesion/Scarring Grade 2 & 3', 'timeFrame': 'Baseline, Day 30, Day 90', 'description': 'Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)'}, {'measure': 'Degree of Inflammation', 'timeFrame': 'Baseline, Day 30, Day 90', 'description': 'Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)'}, {'measure': 'Sino-Nasal Outcome Test (SNOT) 22', 'timeFrame': 'Baseline, Day 30, Day 90', 'description': 'Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Chronic Sinusitis', 'Endoscopic Sinus Surgery'], 'conditions': ['Chronic Sinusitis']}, 'descriptionModule': {'briefSummary': 'This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus ostia.', 'detailedDescription': 'This is a prospective, single-center, single-arm, open label feasibility study aiming to enroll at least 10 patients and a maximum of 15 patients to achieve 30 treated sinuses. The objective of this feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis (CS) patients undergoing sinus surgery of peripheral sinus ostia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is ≥ 18 years of age.\n* Patient is willing and able to comply with protocol requirements.\n* Patient has CS as confirmed by CT scan and defined as symptoms lasting longer than 8 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses.\n* Patient's condition and the planned intervention will involve at least two and a maximum of four peripheral sinuses (frontal or maxillary sinuses or combination of both).\n* Patient is a candidate for a planned intervention involving sinus surgery in the operating room or office setting.\n* Patient has nasal polyps no greater than grade 2.\n* Patient with nasal polyps greater than 2 are eligible after their reduction/removal during ESS without significant complications that would confound the study results and leaving the patient's anatomy amenable to sinus implant placement, as judged by the operating physician.\n* Female patients of child-bearing potential must not be pregnant and must agree to not become pregnant during the course of the study.\n* Female patients of child-bearing potential must agree to use consistent and acceptable method/s of birth control during the course of the study.\n* CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.\n* Patient has a minimum total CT stage (Lund-Mackay method) of 6.\n* Patient has disease in frontal and/or maxillary sinuses confirmed by CT scan.\n* Planned ESS includes bilateral ethmoidectomy (if judged necessary), frontal sinus surgery using Draf II (A or B) dissection and/or balloon dilation, with minimum of 5-mm diameter opening created. In the case of maxillary sinus surgery, traditional antrostomy or balloon dilation, with or without removal of uncinate process, should be performed with minimum of 5-mm diameter opening created.\n* Technique used for frontal or maxillary sinus surgery was the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally)\n* Septoplasty for access to the ostio-meatal complex is permitted.\n\nExclusion Criteria:\n\n* Patient has presence of grade 3 or 4 polyposis, unless removed during surgery and preceding implant placement.\n* Patient has presence of adhesions/scarring grades 3 or 4, unless removed during surgery and preceding implant placement.\n* Patient has known history of immune deficiency (e.g., IGG subclass deficiency or IGA deficiency, HIV).\n* Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, HIV, etc.).\n* Patient has oral-steroid dependent condition such as COPD, asthma or other condition.\n* Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate.\n* Patient has clinical evidence of acute bacterial sinusitis (e.g. acute increase in purulent discharge, fever, facial pain etc.).\n* Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue, etc.).\n* Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90-day period.\n* Patient is currently participating in another clinical trial.\n* Patient has history of insulin dependent diabetes mellitus.\n* Patient has previously undergone ESS and experienced a CSF leak or has residual compromised vision as a result of a complication in a prior ESS procedure.\n* Patient has known dehiscence of the lamina papyracea.\n* Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes simplex, chickenpox or measles).\n* Significant complication during the current peripheral ostia surgery/such as excessive blood loss, CSF leak or punctured lamina papyracea.\n* Current surgical intervention (operating room or office setting) is aborted for any reason."}, 'identificationModule': {'nctId': 'NCT02228720', 'acronym': 'EXCEED', 'briefTitle': 'Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intersect ENT'}, 'officialTitle': 'The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency', 'orgStudyIdInfo': {'id': 'P500-0414'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propel Nova Sinus Implant', 'description': 'Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days', 'interventionNames': ['Device: Propel Nova Sinus Implant']}], 'interventions': [{'name': 'Propel Nova Sinus Implant', 'type': 'DEVICE', 'otherNames': ['Propel Contour Sinus Implant (mometasone furoate, 370 mcg)'], 'description': 'Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days', 'armGroupLabels': ['Propel Nova Sinus Implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida ENT Associates', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sinus Institute', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}], 'overallOfficials': [{'name': 'William J. Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Florida ENT Associates, PA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intersect ENT', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}