Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT04923867
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2021-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Suturable DuraGen™ PMCF Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-15', 'releaseDate': '2025-08-28'}], 'estimatedResultsFirstSubmitDate': '2025-08-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2021-06-10', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Outcome', 'timeFrame': 'post-up to 90 days', 'description': 'Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Adverse Event', 'timeFrame': 'Between days 30-90', 'description': 'Adverse event that occurred between days 30-90 post-operatively'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cerebrospinal Fluid Leak']}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.', 'detailedDescription': 'This is a multicenter, non-randomized, non-interventional, retrospective Post-Market Clinical Follow-up (PMCF) study to evaluate the occurrence of post-operative cerebrospinal fluid (CSF) leaks within 30 days (and up to 90 days) after use of Suturable DuraGen™ for a supratentorial, infratentorial, or spinal procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neurosurgery service in Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is between 18 and 80 years of age\n2. Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation\n3. Availability of post-operative assessment results.\n\nExclusion Criteria:\n\n1\\. There are no exclusionary criteria for this study population'}, 'identificationModule': {'nctId': 'NCT04923867', 'briefTitle': 'Suturable DuraGen™ PMCF Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™', 'orgStudyIdInfo': {'id': 'C-DGSUT-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Supratentorial Procedure Group', 'description': 'Subjects that have undergone a supratentorial procedure with the use of Suturable DuraGen™.', 'interventionNames': ['Device: Suturable DuraGen™']}, {'label': 'Infratentorial Procedure Group', 'description': 'Subjects that have undergone a infratentorial procedure with the use of Suturable DuraGen™.', 'interventionNames': ['Device: Suturable DuraGen™']}, {'label': 'Spinal Procedure Group', 'description': 'Subjects that have undergone a spinal procedure with the use of Suturable DuraGen™.', 'interventionNames': ['Device: Suturable DuraGen™']}], 'interventions': [{'name': 'Suturable DuraGen™', 'type': 'DEVICE', 'description': 'Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.', 'armGroupLabels': ['Infratentorial Procedure Group', 'Spinal Procedure Group', 'Supratentorial Procedure Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Medical Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Andrew Tummon', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Integra LifeSciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-28', 'type': 'RELEASE'}, {'date': '2025-09-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Integra LifeSciences Corporation'}}}}