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

Collagen Matrix

Status: Not yet enrolling

Conditions: Repair of Dura Mater

Treatments: Other: Post-market Study

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07217132

CIP.033.2

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 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
• Patient is 18 years or older
• Patient of child-bearing potential is not pregnant or nursing

Exclusion criteria

• Patients with a known history of hypersensitivity to bovine derived materials
• Patients that are non-English speaking
• Subjects requiring Legally Authorized Representative