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

Collagen Matrix

Status: Enrolling

Conditions: Repair of Dura Mater

Study type: Observational

Funder types: Industry

Identifiers

NCT06822920

CIP.010

Details and patient eligibility

About

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

Full 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.

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.

Exclusion criteria

• There are no subject restrictions for the study other than patients with known allergy to bovine collagen products as specified in the contraindications of the Instructions for Use.