Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-31 @ 12:45 PM
Study NCT ID:
NCT00791934
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2008-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012852', 'term': 'Sinusitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lenglan1@its.jnj.com', 'phone': '650-687-5888', 'title': 'Clinical Director', 'organization': 'Acclarent, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 10 weeks', 'description': 'Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting', 'eventGroups': [{'id': 'EG000', 'title': 'Stratus Microflow Ethmoid Spacer', 'description': 'Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days', 'otherNumAtRisk': 63, 'otherNumAffected': 19, 'seriousNumAtRisk': 63, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Headache', 'notes': 'Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Pain', 'notes': 'Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Stuffiness', 'notes': 'Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Wing Detachment from device', 'notes': 'Device wing separated from the body of the device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stratus Microflow Ethmoid Spacer', 'description': 'Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.91', 'spread': '1.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks post-procedure', 'description': "The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 58 of the 63 subjects had paired baseline and 10 week post-procedure CT scans available for analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stratus Microflow Ethmoid Spacer', 'description': 'Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 weeks post surgery', 'description': "The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes paired data for 53 subjects with baseline and 10 week visual acuity data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stratus Microflow Ethmoid Spacer', 'description': 'Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 weeks post-procedure', 'description': 'Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of \\> 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes paired data for 53 of the 63 subjects with intraocular pressure (IOP) evaluations available for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stratus Microflow Ethmoid Spacer', 'description': 'Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.36', 'spread': '1.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': "The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of the 47 subjects with 1 year post-procedure SNOT-20 scores.'}, {'type': 'SECONDARY', 'title': 'Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stratus Microflow Ethmoid Spacer', 'description': 'Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.54', 'spread': '0.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': "The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of the 58 subjects with 10 week post-procedure SNOT-20 scores available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stratus Microflow Ethmoid Spacer', 'description': 'Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Follow-up extended to 1 yr. 13 subjects chose not to participate in the extension.', 'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Did not consent for extended follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Stratus Microflow Ethmoid Spacer', 'description': 'Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.24', 'spread': '14.87', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '39', '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': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2008-11-13', 'resultsFirstSubmitDate': '2014-05-06', 'studyFirstSubmitQcDate': '2008-11-13', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-06-10', 'studyFirstPostDateStruct': {'date': '2008-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.', 'timeFrame': '10 weeks post-procedure', 'description': "The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)', 'timeFrame': '10 weeks post surgery', 'description': "The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint."}, {'measure': 'Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg', 'timeFrame': '10 weeks post-procedure', 'description': 'Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of \\> 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).'}, {'measure': 'Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline', 'timeFrame': '1 year', 'description': "The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5."}, {'measure': 'Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline', 'timeFrame': '10 weeks', 'description': "The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sinusitis']}, 'descriptionModule': {'briefSummary': 'Study Design:\n\nA non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects age 17 years or older\n* Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of scheduled surgery)\n* Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of antibiotics)\n\nExclusion Criteria:\n\n* Age \\< 17 years old\n* History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP \\>21 mmHg)\n* Adequate anatomical distances for treatment\n* Patient received oral steroid treatment within two weeks prior to day of surgery\n* Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent device placement\n* Sinonasal tumors or obstructive lesions\n* History of facial trauma that distorts sinus anatomy and precludes access to the ethmoid sinus\n* Contracted/underdeveloped ethmoid sinus\n* Dehiscent lamina orbitalis\n* Previous ethmoid surgery\n* Ethmoid mucocele\n* Extensive Nasal Polyps\n* Asthmatic patients with aspirin sensitivity\n* Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT00791934', 'acronym': 'DELIVER', 'briefTitle': 'Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40)', 'orgStudyIdInfo': {'id': 'CPR005003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stratus Microflow Ethmoid Spacer', 'description': 'Temporary implantation of Ethmoid spacer with Triamcinolone Acetonide for 28 days.', 'interventionNames': ['Device: Stratus Microflow Ethmoid Spacer']}], 'interventions': [{'name': 'Stratus Microflow Ethmoid Spacer', 'type': 'DEVICE', 'otherNames': ['Ethmoid Spacer'], 'description': 'The Spacer is inserted surgically into the ethmoid complex through the use of a sinus access system. Triamcinolone acetonide will be administered into the Spacer for this investigational study. The Spacer will be left in the ethmoid sinus for a period of 28 days. At the end of the implant period, the device is removed with standard instrumentation, during a follow-up office visit.', 'armGroupLabels': ['Stratus Microflow Ethmoid Spacer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}], 'overallOfficials': [{'name': 'Peter Catalano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahey Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Acclarent', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}