Monitoring the use of Collagen Dura Membranes for dural repair
Monitoring the Use of Collagen Dura Membrane in the Post-market Phase
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 |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Collagen Matrix Industry-sponsored |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06822920 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with a dural defect requiring repair with a dural substitute.
Not a fit: Patients with known allergies to bovine collagen products will not benefit from this study.
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 performed: While this approach is being monitored in a post-market setting, similar studies have shown promise in evaluating the safety of medical devices.
Eligibility criteria
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 this trial is running
Milwaukee, Wisconsin
- Medical Collagen of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Meenakshi Paliwal
- Email: mpaliwal@regenity.com
- Phone: 2014051477
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.