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

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

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

Study Overview

• Status: Recruiting
• Conditions: Repair of Dura Mater
• Intervention / Treatment: Other: Post Market Study

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 118

Contacts and Locations

• Study Contact: Name: Meenakshi Paliwal; Phone Number: 324 2014051477; Email: mpaliwal@regenity.com
• Study Contact Backup: Name: Peggy Hansen; Phone Number: 304 201-405-1477; Email: phansen@regenity.com

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University
      • Principal Investigator: Scott Rahimi, MD
      • Contact: Candelario Laserna, MD; Email: CALASERNA@augusta.edu
      • Contact: Natasha Flores; Email: nflores@augusta.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Sophie A Munn; Email: samunn@mgh.harvard.edu
      • Contact: Erica Fox; Email: efox15@mgh.harvard.edu
      • Principal Investigator: Brian Nahed, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Revision Surgery	Adequate healing of dural defects without need for a revision surgery or second intervention	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Adverse events	Rate of product-related adverse events or complications	8 weeks

Collaborators and Investigators

• Sponsor: Collagen Matrix

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): January 31, 2025

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CIP.057_DMOP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes