NCT07217132

Clinical Investigation Plan - Post-market Clinical Follow-up Study Collagen Dura Membrane - Suturable

Monitoring the Use of Collagen Dura Membrane - Suturable (DMS) in the Post-market Phase

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 54 (estimated)
• Sponsor: Collagen Matrix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Monitoring the use of Collagen Dura Membrane - Suturable (DMS) in the post-market phase

Detailed description

A prospective, post-market clinical study at a maximum of three sites, with an enrollment of 54 subjects. The primary endpoint of the study will be the rate of adverse events related to the Subject Device requiring surgical intervention. The date of each event will be recorded and assessed, including at least one timepoint of 9 months of more post-operatively. Secondary endpoints will include all adverse events (i.e., infection, CSF Leak, and Pseudomeningocele), score of adequacy of product performance, score for product handling at implantation, and score for product adaptability at implantation. No original patient records or patient 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: 2025-12-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-10-15
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States