Recruiting

Collagen Dura Membranes

Sponsor:

Collagen Matrix

Code:

NCT06822920

Conditions

Repair of Dura Mater

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Repair of Dura Mater

Study ID

NCT06822920

Start date

Jan 3, 2025

Status verified date

Feb, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

110 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Measurement of the occurrence of adverse event requiring surgical intervention [ Time Frame: 6-9 months ]

Central Contacts and Locations

Central contacts

Meenakshi Paliwal

2014051477mpaliwal@regenity.com

Peggy Hansen

201-405-1477phansen@regenity.com

Locations

Medical Collagen of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Collagen Matrix

Last update posted

Feb 12, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Collagen Matrix on 2025-02-12.