Recruiting

DuraMatrix-Onlay Plus

Sponsor:

Collagen Matrix

Code:

NCT06802133

Conditions

Repair of Dura Mater

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Post Market Study

Study Details

Brief summary:

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

Conditions

Repair of Dura Mater

Study ID

NCT06802133

Start date

Jan 13, 2025

Status verified date

Oct, 2025

Completion date

Jul 30, 2026

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

118 participants

Anticipated

Interventions and Outcome Measures

Interventions

Post Market Study

Prospective case series without a concurrent comparator group.

Primary outcome measure

  • Rate of Revision Surgery [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Meenakshi Paliwal

2014051477mpaliwal@regenity.com

Peggy Hansen

201-405-1477phansen@regenity.com

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Candelario Laserna, MD

CALASERNA@augusta.edu

Natasha Flores

NFLORES@augusta.edu

Principal Investigator:

Scott Rahimi, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Sophie A Munn

samunn@mgh.harvard.edu

Erica Fox

efox15@mgh.harvard.edu

Principal Investigator:

Brian Nahed, MD

More Information

Sponsor

Collagen Matrix

Last update posted

Oct 15, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Collagen Matrix on 2025-10-15.