NCT06822920

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

Monitoring the Use of Collagen Dura Membrane in the Post-market Phase

• Status: 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 Membrane in the Post-market phase

Detailed description

A multi-center clinical series of 110 patients treated with Collagen Dura Substitute Membrane (DuraMatrix \& DuraMatrix Onlay) for a dural defect in the dura mater will be evaluated prospectively. Patients will have follow-up time points through at least 6-9 months which align with the lifetime of the device. The primary endpoint of the study will be the presence of adverse events leakage that require surgical intervention, will be evaluated at each follow-up time point. The secondary endpoint of the study will be adverse events i.e. infection, Cerebrospinal fluid leak (CSF) and Pseudomeningocele. No patient records or personal identifying information will be disclosed to Collagen Matrix.

Conditions

• Repair of Dura Mater

Timeline

• Start date: 2025-01-03
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: United States