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

Overview

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

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

Interventions

Eligibility

Locations (1)

Outcomes

Central Contacts