Clinical Investigation Plan - Post-market Clinical Follow-up Study Collagen Dura Membrane - Suturable
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Collagen Matrix
- Study ID
- NCT07217132
- Status
- Not Yet Recruiting
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Conditions
- Repair of Dura Mater
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Post-market Study — OTHERProspective case series without a concurrent comparator group.
Study Details
Monitoring the use of Collagen Dura Membrane - Suturable (DMS) in the post-market phase
Key Dates
- Start date
- Dec 1, 2025
- Status verified
- Oct 2025
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 54 participants (estimated)
Primary Outcome Measure
Rate of Adverse Events Requiring Surgical Intervention [ Time Frame: 9 months ]
Central Contacts
- Meenakshi Paliwal2014051477
- Peggy Hansen2014051477
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baptist Health South Florida | Miami | Florida | 33176 | Michael W McDermott, MD (PRINCIPAL_INVESTIGATOR) |
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