Post-market Clinical Investigation Plan: Collagen Dura Regeneration Membrane - Repair (DMR)

Collagen Matrix

Status: Not yet enrolling

Conditions: Repair of Dura Mater

Study type: Observational

Funder types: Industry

Identifiers

NCT07371091

CIP.088

Details and patient eligibility

About

Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.

Full description

A multi-center (up to 4 sites) clinical case series of 110 patients treated with Collagen Dura Regeneration Membrane - Repair (DMR) for a dural defect in the dura mater will be evaluated prospectively. The primary endpoint is the rate of adverse events related to the Subject Device requiring surgical intervention. Patients will have a follow-up evaluation post-operatively in line with standard or care of the study site, and 8 months after the initial surgery. No original patient records or personal identifying information will be disclosed to CMI.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a dural defect requiring repair with a dural substitute as per routine clinical practice
• Patient is 18 years or older
• Patient of child-bearing potential is not pregnant or nursing
• Participant is willing and able to provide consent

Exclusion criteria

• Patients with a known history of hypersensitivity to bovine derived materials
• Patients that are non-English speaking
• Patients requiring legal representation