Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT07217132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-15
First Post:
2025-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Investigation Plan - Post-market Clinical Follow-up Study Collagen Dura Membrane - Suturable
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': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2025-10-13', 'studyFirstSubmitQcDate': '2025-10-13', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Adverse Events Requiring Surgical Intervention', 'timeFrame': '9 months', 'description': 'Rate of adverse events related to subject device and requiring surgical intervention.'}], 'secondaryOutcomes': [{'measure': 'Rate of Adverse Events', 'timeFrame': '9 months', 'description': 'Rate of all product related adverse events or complications.'}, {'measure': 'Score of adequacy of product performance', 'timeFrame': '9 months', 'description': 'rated yes/no by clinician'}, {'measure': 'Score for Product Handling at Implantation', 'timeFrame': '9 months', 'description': 'Rated on a scale from 1 (poor) to 4 (excellent) by clinician.'}, {'measure': 'Score for Product Adaptability at Implantation', 'timeFrame': '9 months', 'description': 'Rate on a scale of 1 (poor) to 4 (excellent) by clinician.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Repair of Dura Mater']}, 'descriptionModule': {'briefSummary': 'Monitoring the use of Collagen Dura Membrane - Suturable (DMS) in the post-market phase', 'detailedDescription': 'A prospective, post-market clinical study at a maximum of three sites, with an enrollment of 54 subjects. The primary endpoint of the study will be the rate of adverse events related to the Subject Device requiring surgical intervention. The date of each event will be recorded and assessed, including at least one timepoint of 9 months of more post-operatively. Secondary endpoints will include all adverse events (i.e., infection, CSF Leak, and Pseudomeningocele), score of adequacy of product performance, score for product handling at implantation, and score for product adaptability at implantation.\n\nNo original patient records or patient 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* Patients with a dural defect requiring repair with a dural substitute\n* Patient is 18 years or older\n* Patient of child-bearing potential is not pregnant or nursing\n\nExclusion Criteria:\n\n* Patients with a known history of hypersensitivity to bovine derived materials\n* Patients that are non-English speaking\n* Subjects requiring Legally Authorized Representative'}, 'identificationModule': {'nctId': 'NCT07217132', 'briefTitle': 'Clinical Investigation Plan - Post-market Clinical Follow-up Study Collagen Dura Membrane - Suturable', 'organization': {'class': 'INDUSTRY', 'fullName': 'Collagen Matrix'}, 'officialTitle': 'Monitoring the Use of Collagen Dura Membrane - Suturable (DMS) in the Post-market Phase', 'orgStudyIdInfo': {'id': 'CIP.033.2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Post-market Study', 'type': 'OTHER', 'description': 'Prospective case series without a concurrent comparator group.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Starlie Belnap, PhD', 'role': 'CONTACT', 'email': 'starlieb@baptisthealth.net', 'phone': '7865961825'}, {'name': 'Michael W McDermott, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baptist Health South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Meenakshi Paliwal', 'role': 'CONTACT', 'email': 'mpaliwal@regenity.com', 'phone': '2014051477', 'phoneExt': '324'}, {'name': 'Peggy Hansen', 'role': 'CONTACT', 'email': 'phansen@regenity.com', 'phone': '2014051477', 'phoneExt': '304'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Collagen Matrix', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Baptist Health South Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}