NCT06802133

Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)

Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 118 (estimated)
• Sponsor: Collagen Matrix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.

Detailed description

A prospective, post-market, open label clinical study at a maximum of 8 sites, with an enrollment of 118 subjects. The primary endpoint of the study will be the rate of revision surgery. The presence of adverse events will be evaluated at each follow-up time point i.e. CSF leak, infection and Pseudomeningocele. Patients will have a follow-up evaluation at least at 8 weeks post initial surgery date (which align with the approximate resorption time of the device) where possible and as deemed necessary by a clinician. No original patient records or personal identifying information will be disclosed to Collagen Matrix.

Conditions

• Repair of Dura Mater

Interventions

Type	Name	Description
OTHER	Post Market Study	Prospective case series without a concurrent comparator group.

Timeline

• Start date: 2025-01-13
• Primary completion: 2026-05-30
• Completion: 2026-07-30
• First posted: 2025-01-31
• Last updated: 2025-10-15

Locations

2 sites across 1 country: United States