Monitoring the use of Collagen Dura Membranes for dural repair
Official title: Monitoring the Use of Collagen Dura Membrane in the Post-market Phase
Run by Collagen Matrix · NCT06822920 · Data updated 2026-11-12
This study is testing how well a new collagen membrane works for repairing dural defects in patients and if it causes any problems like leaks or infections over the next 6 to 9 months.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Collagen Matrix Industry-sponsored |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Status | Recruiting |
| Started | January 3, 2025 |
| Main results expected | September 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | February 12, 2025 |
| Trial ID | NCT06822920 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with a dural defect requiring repair with a dural substitute.
✕Probably not a fit
Patients with known allergies to bovine collagen products will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the use of Collagen Dura Substitute Membrane in patients with dural defects. A total of 110 patients will be treated and monitored over a follow-up period of 6-9 months to assess the safety and effectiveness of the membrane. The primary focus is on identifying any adverse events, such as leakage that necessitates surgical intervention, while secondary endpoints include monitoring for infections and cerebrospinal fluid leaks. Patient confidentiality will be maintained, with no personal information shared with the sponsor.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of dural repair procedures using collagen membranes.
How similar studies have gone: While this approach is being monitored in a post-market setting, similar studies have shown promise in evaluating the safety of medical devices.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a dural defect requiring repair with a dural substitute. Exclusion Criteria: * 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.
Where it's running
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Medical Collagen of Wisconsin
Milwaukee, Wisconsin, United States Recruiting
Study contacts
- Study coordinator: Meenakshi Paliwal
- Email: mpaliwal@regenity.com
- Phone: 2014051477
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Dura repair with DuraMatrix‑Onlay Plus collagen patch
This will try DuraMatrix‑Onlay Plus, a collagen patch, to seal and repair the dura in patients who need a dura substitute during neurosurgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.