Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT06822920
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of the occurrence of adverse event requiring surgical intervention', 'timeFrame': '6-9 months'}], 'secondaryOutcomes': [{'measure': 'Adverse events i.e., infection, CSF leak and Pseudomeningocele', 'timeFrame': '6-9 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Repair of Dura Mater']}, 'descriptionModule': {'briefSummary': 'Monitoring the Use of Collagen Dura Membrane in the Post-market phase', 'detailedDescription': 'A multi-center clinical series of 110 patients treated with Collagen Dura Substitute Membrane (DuraMatrix \\& DuraMatrix Onlay) for a dural defect in the dura mater will be evaluated prospectively. Patients will have follow-up time points through at least 6-9 months which align with the lifetime of the device. The primary endpoint of the study will be the presence of adverse events leakage that require surgical intervention, will be evaluated at each follow-up time point. The secondary endpoint of the study will be adverse events i.e. infection, Cerebrospinal fluid leak (CSF) and Pseudomeningocele. No patient records or personal identifying information will be disclosed to Collagen Matrix.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The subject device is intended for all patient populations. The following population is excluded from the study:-\n\n* Pregnant Women\n* Subjects requiring Legally Authorized Representative\n* Subjects under 18 years of age', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a dural defect requiring repair with a dural substitute.\n\nExclusion Criteria:\n\n* There are no subject restrictions for the study other than patients with known allergy to bovine collagen products as specified in the contraindications of the Instructions for Use.'}, 'identificationModule': {'nctId': 'NCT06822920', 'acronym': 'DM&DMO', 'briefTitle': 'Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Collagen Matrix'}, 'officialTitle': 'Monitoring the Use of Collagen Dura Membrane in the Post-market Phase', 'orgStudyIdInfo': {'id': 'CIP.010'}}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaitlin Goetschel', 'role': 'CONTACT'}], 'facility': 'Medical Collagen of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], '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'}}}}