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

Collagen Matrix

Status: Enrolling

Conditions: Repair of Dura Mater

Treatments: Other: Post Market Study

Study type: Observational

Funder types: Industry

Identifiers

NCT06802133

CIP.057_DMOP

Details and patient eligibility

About

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

Full 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.

Enrollment: 118 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The general population will be included in the study where a dura substitute is required for the repair of dura mater.

Exclusion criteria

• Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.