Status:
NOT_YET_RECRUITING
Clinical Investigation Plan - Post-market Clinical Follow-up Study Collagen Dura Membrane - Suturable
Lead Sponsor:
Collagen Matrix
Collaborating Sponsors:
Baptist Health South Florida
Conditions:
Repair of Dura Mater
Eligibility:
All Genders
18+ years
Brief Summary
Monitoring the use of Collagen Dura Membrane - Suturable (DMS) in the post-market phase
Detailed Description
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 De...
Eligibility Criteria
Inclusion
- Patients with a dural defect requiring repair with a dural substitute
- Patient is 18 years or older
- Patient of child-bearing potential is not pregnant or nursing
Exclusion
- Patients with a known history of hypersensitivity to bovine derived materials
- Patients that are non-English speaking
- Subjects requiring Legally Authorized Representative
Key Trial Info
Start Date :
December 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT07217132
Start Date
December 1 2025
End Date
September 1 2027
Last Update
October 15 2025
Active Locations (1)
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1
Baptist Health South Florida
Miami, Florida, United States, 33176