Trials / Not Yet Recruiting
Not Yet RecruitingNCT07371091
Post-market Clinical Investigation Plan: Collagen Dura Regeneration Membrane - Repair (DMR)
Monitoring the Use of Collagen Dura Membrane - Repair (DMR) in the Post-market Phase
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 110 (estimated)
- Sponsor
- Collagen Matrix · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.
Detailed description
A multi-center (up to 4 sites) clinical case series of 110 patients treated with Collagen Dura Regeneration Membrane - Repair (DMR) for a dural defect in the dura mater will be evaluated prospectively. The primary endpoint is the rate of adverse events related to the Subject Device requiring surgical intervention. Patients will have a follow-up evaluation post-operatively in line with standard or care of the study site, and 8 months after the initial surgery. No original patient records or personal identifying information will be disclosed to CMI.
Conditions
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2026-01-27
- Last updated
- 2026-01-27
Source: ClinicalTrials.gov record NCT07371091. Inclusion in this directory is not an endorsement.