Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)

Launched by COLLAGEN MATRIX · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the use of Collagen Dura Membranes, which are materials used to repair a part of the brain called the dura mater. The study is in the post-market phase, meaning that these membranes are already available for use, and the trial aims to monitor their effectiveness and safety as they are used in patients. The trial is currently recruiting people aged 65 to 74, and anyone of any gender can participate.

To be eligible for this study, patients must have a specific type of injury known as a dural defect that needs repair with a special material called a dural substitute. The only main restriction is that individuals who are allergic to bovine collagen (a type of protein derived from cows) cannot join the study. If you decide to participate, you can expect to be monitored closely to assess how well the Collagen Dura Membrane works for your repair. This trial is important because it helps ensure that this treatment remains safe and effective for patients in the future.

Gender

ALL

Eligibility 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.