Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-31 @ 8:59 PM
Study NCT ID:
NCT01894503
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2013-07-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068656', 'term': 'Mometasone Furoate'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jstambaugh@intersectent.com', 'phone': '650-641-2103', 'title': 'James Stambaugh, Vice President of Clinical & Medical Affairs', 'organization': 'Intersect ENT, Inc.'}, 'certainAgreement': {'otherDetails': "There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events and Serious Adverse Events were recorded and tabulated through Day 90.', 'eventGroups': [{'id': 'EG000', 'title': 'S8 Sinus Implant', 'description': 'Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate sinus implant, 1350 mcg) in the ethmoid sinuses S8 Sinus Implant (mometasone furoate, 1350 mcg): Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'notes': 'Mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute sinusitis', 'notes': 'Mild, maxillary sinus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Sinuses With Successful Implant Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S8 Sinus Implant', 'description': 'Implant delivery success'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'End of baseline procedure', 'description': 'Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure', 'unitOfMeasure': 'Sinuses', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sinuses', 'denomUnitsSelected': 'Sinuses', 'populationDescription': 'Per-treatment evaluable population, consisting of all sinuses in which placement of the S8 Sinus Implant was attempted.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S8 Sinus Implant', 'description': 'In-office bilateral placement of the S8 Sinus Implant (1350 mcg of mometasone furoate) in the ethmoid sinuses'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 3, 7, 14, 21 and 30', 'description': 'Concentration of mometasone furoate was determined in blood samples collected at baseline, Days 3, 7, 14, 21 and 30 using a validated method with the lowest level of quantification (LLOQ) of 30 pg/ml.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-treatment evaluable population consisting of all patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'S8 Sinus Implant', 'description': 'Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate sinus implant, 1350 mcg) in the ethmoid sinuses S8 Sinus Implant (mometasone furoate, 1350 mcg): Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A prospective, single-center open label study treating adult patients with recurrent polyposis after bilateral total ethmoidectomy. Study period 9 July 2013 to 17 July 2013', 'preAssignmentDetails': 'A total of six patients were enrolled (consented). One patient did not have the required grade 2 polyposis on at least one ethmoid side and was excluded. The remaining five patients meet all eligibility criteria and underwent an in-office bilateral placement of two S8 Sinus Implants. All five patients completed follow-up through the Day 90 visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Demographic and Baseline Clinical Characteristics', 'description': 'In-office bilateral placement of two S8 Sinus Implants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.2', 'groupId': 'BG000', 'lowerLimit': '37', 'upperLimit': '58'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'dispFirstSubmitDate': '2015-03-19', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-22', 'studyFirstSubmitDate': '2013-07-03', 'dispFirstSubmitQcDate': '2015-03-19', 'resultsFirstSubmitDate': '2018-04-10', 'studyFirstSubmitQcDate': '2013-07-03', 'dispFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-23', 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Sinuses With Successful Implant Delivery', 'timeFrame': 'End of baseline procedure', 'description': 'Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ', 'timeFrame': 'Days 3, 7, 14, 21 and 30', 'description': 'Concentration of mometasone furoate was determined in blood samples collected at baseline, Days 3, 7, 14, 21 and 30 using a validated method with the lowest level of quantification (LLOQ) of 30 pg/ml.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Sinusitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.', 'detailedDescription': 'The S8 PK study was a single-center, open label study treating 5 adult (18 years or older) patients diagnosed with chronic sinusitis, who had undergone prior bilateral total ethmoidectomy and later presented with recurrent nasal obstruction/congestion symptoms and bilateral ethmoid polyposis. The S8 PK study assessed the safety, implant delivery to the ethmoid sinus, and systemic exposure to mometasone furoate (MF) by measuring plasma MF and cortisol concentrations through 30 days post-procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosis of chronic sinusitis\n* Prior bilateral total ethmoidectomy\n* Recurrent sinus obstruction due to polyps grade 2 or higher\n\nKey Exclusion Criteria:\n\n* Required use of mometasone furoate within 2 weeks prior to implant procedure\n* Significant scarring or adhesions of the sinus'}, 'identificationModule': {'nctId': 'NCT01894503', 'acronym': 'S8PK', 'briefTitle': 'Safety and Performance of the Steroid-Releasing S8 Sinus Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intersect ENT'}, 'officialTitle': 'A Clinical Evaluation of the Safety and Performance of the Steroid-Releasing S8 Sinus Implant When Used in Post-Sinus Surgery Patients With Recurrent Sinus Polyps', 'orgStudyIdInfo': {'id': 'P500-0513'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S8 Sinus Implant', 'description': 'Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses', 'interventionNames': ['Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)']}], 'interventions': [{'name': 'S8 Sinus Implant (mometasone furoate, 1350 mcg)', 'type': 'DRUG', 'otherNames': ['SINUVA (mometasone furoate) sinus implant'], 'description': 'Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days', 'armGroupLabels': ['S8 Sinus Implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sacramento ENT', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Randall Ow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sacramento ENT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intersect ENT', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}