Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 1:39 PM
Study NCT ID:
NCT06802133
Status:
RECRUITING
Last Update Posted:
2025-10-15
First Post:
2025-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Revision Surgery', 'timeFrame': '8 weeks', 'description': 'Adequate healing of dural defects without need for a revision surgery or second intervention'}], 'secondaryOutcomes': [{'measure': 'Rate of Adverse events', 'timeFrame': '8 weeks', 'description': 'Rate of product-related adverse events or complications'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Repair of Dura Mater']}, 'descriptionModule': {'briefSummary': 'Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.', 'detailedDescription': 'A prospective, post-market, open label clinical study at a maximum of 8 sites, with an enrollment of 118 subjects. The primary endpoint of the study will be the rate of revision surgery. The presence of adverse events will be evaluated at each follow-up time point i.e. CSF leak, infection and Pseudomeningocele. Patients will have a follow-up evaluation at least at 8 weeks post initial surgery date (which align with the approximate resorption time of the device) where possible and as deemed necessary by a clinician.\n\nNo original patient records or personal identifying information will be disclosed to Collagen Matrix.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The general population will be included in the study where a dura substitute is required for the repair of dura mater', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The general population will be included in the study where a dura substitute is required for the repair of dura mater.\n\nExclusion Criteria:\n\n* Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.'}, 'identificationModule': {'nctId': 'NCT06802133', 'briefTitle': 'Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Collagen Matrix'}, 'officialTitle': 'Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.', 'orgStudyIdInfo': {'id': 'CIP.057_DMOP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Post Market Study', 'type': 'OTHER', 'description': 'Prospective case series without a concurrent comparator group.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Candelario Laserna, MD', 'role': 'CONTACT', 'email': 'CALASERNA@augusta.edu'}, {'name': 'Natasha Flores', 'role': 'CONTACT', 'email': 'NFLORES@augusta.edu'}, {'name': 'Scott Rahimi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sophie A Munn', 'role': 'CONTACT', 'email': 'samunn@mgh.harvard.edu'}, {'name': 'Erica Fox', 'role': 'CONTACT', 'email': 'efox15@mgh.harvard.edu'}, {'name': 'Brian Nahed, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Meenakshi Paliwal', 'role': 'CONTACT', 'email': 'mpaliwal@regenity.com', 'phone': '2014051477', 'phoneExt': '324'}, {'name': 'Peggy Hansen', 'role': 'CONTACT', 'email': 'phansen@regenity.com', 'phone': '201-405-1477', 'phoneExt': '304'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Collagen Matrix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}