Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-09 @ 4:44 PM
Study NCT ID:
NCT00912405
Status:
COMPLETED
Last Update Posted:
2015-04-20
First Post:
2009-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jstambaugh@intersectent.com', 'phone': '650-641-2103', 'title': 'James Stambaugh', 'organization': 'Intersect ENT'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sinexus Intranasal Splint', 'description': 'Patient receives a drug-coated intranasal splint\n\nSteroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)', 'otherNumAtRisk': 50, 'otherNumAffected': 23, 'seriousNumAtRisk': 50, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'seriousEvents': [{'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'number of sinuses', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sinexus Intranasal Splint', 'description': 'Patient receives a drug-coated intranasal splint\n\nSteroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2.49', 'upperLimit': '13.95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'Number of Sinuses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of sinuses', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Device Placement Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'Sinuses Attempted', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sinexus Intranasal Splint', 'description': 'Patient receives a drug-coated intranasal splint\n\nSteroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of procedure', 'description': 'A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.', 'unitOfMeasure': 'Sinuses', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sinuses Attempted', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sinexus Intranasal Splint', 'description': 'Patient receives a drug-coated intranasal splint\n\nSteroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 30 days', 'description': 'Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.', 'unitOfMeasure': 'Pts. w/ significant IOP elevation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Sinuses With Significant Post-operative Adhesion Formation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'Sinuses', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sinexus Intranasal Splint', 'description': 'Patient receives a drug-coated intranasal splint\n\nSteroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.', 'unitOfMeasure': 'sinuses', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sinuses', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sinexus Intranasal Splint', 'description': 'Patient receives a drug-coated intranasal splint\n\nSteroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sinexus Intranasal Splint', 'description': 'Patient receives a drug-coated intranasal splint\n\nSteroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'spread': '13.1', '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': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lund MacKay CT Stage', 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '5.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Lund Mackay CT Staging system is a scale ranging from 0 to 24, where lower scores represent a better condition. each sinus is scored 0, 1 or 2, where 0=no opacification, 1=partial opacification and 2=complete opacification. 12 areas of the anatomy are evaluated, resulting in the scale ranging from 0 to 24.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Proportion of Patients with Polyps', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Proportion of Patients Undergoing Revision Surgery', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2009-06-01', 'resultsFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2009-06-02', 'lastUpdatePostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-25', 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)', 'timeFrame': '30 days'}, {'measure': 'Device Placement Success Rate', 'timeFrame': 'At the time of procedure', 'description': 'A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.'}], 'secondaryOutcomes': [{'measure': 'Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities', 'timeFrame': 'Baseline and 30 days', 'description': 'Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.'}, {'measure': 'Number of Sinuses With Significant Post-operative Adhesion Formation', 'timeFrame': '30 days', 'description': 'Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients diagnosed with Chronic Sinusitis undergoing functional endoscopic surgery (FESS)'], 'conditions': ['Chronic Sinusitis']}, 'descriptionModule': {'briefSummary': 'This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is 18 years of age or older\n* Patient has a diagnosis of chronic sinusitis\n* Patient has a clinical indication for and has consented to FESS\n* Patient CT scan confirms CS diagnosis within 6 months of procedure\n* CT sacn confirms presence of disease in ethmoid sinus(es)\n* Planned FESS includes unilateral or bilateral total ethmoidectomy\n\nExclusion Criteria:\n\n* Immune deficiency (IGG subclass deficiency or IGA deficiency)\n* Oral-steroid dependent COPD, asthma or other condition\n* Clinical evidence of acute bacterial sinusitis\n* History or diagnosis of glaucoma or ocular hypertension\n* Clinical evidence or suspicion of invasive fungal sinusitis\n* Evidence of disease or condition expected to compromise survival or ability to complete follow-up\n* Known history of allergy or intolerance to corticosteroids\n* History of insulin dependent diabetes'}, 'identificationModule': {'nctId': 'NCT00912405', 'briefTitle': 'Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intersect ENT'}, 'officialTitle': 'A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis', 'orgStudyIdInfo': {'id': 'P500-0209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sinexus Intranasal Splint', 'description': 'Patient receives a drug-coated intranasal splint', 'interventionNames': ['Device: Steroid-Eluting Sinexus Intranasal Splint']}], 'interventions': [{'name': 'Steroid-Eluting Sinexus Intranasal Splint', 'type': 'DEVICE', 'description': 'Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)', 'armGroupLabels': ['Sinexus Intranasal Splint']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Central California Ear, Nose Thraot', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intersect ENT', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}