Post-market Clinical Investigation Plan: Collagen Dura Regeneration Membrane - Repair (DMR)

May 27, 2026 updated by: Collagen Matrix

Monitoring the Use of Collagen Dura Membrane - Repair (DMR) in the Post-market Phase

Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

A multi-center (up to 4 sites) clinical case series of 110 patients treated with Collagen Dura Regeneration Membrane - Repair (DMR) for a dural defect in the dura mater will be evaluated prospectively. The primary endpoint is the rate of adverse events related to the Subject Device requiring surgical intervention. Patients will have a follow-up evaluation post-operatively in line with standard or care of the study site, and 8 months after the initial surgery. No original patient records or personal identifying information will be disclosed to CMI.

Study Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Stephan Munich, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
        • Principal Investigator:
          • Brian Nahed, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with a dural defect requiring repair with a dural substitute.

Description

Inclusion Criteria:

  • Patients with a dural defect requiring repair with a dural substitute as per routine clinical practice
  • Patient is 18 years or older
  • Patient of child-bearing potential is not pregnant or nursing
  • Participant is willing and able to provide consent

Exclusion Criteria:

  • Patients with a known history of hypersensitivity to bovine derived materials
  • Patients that are non-English speaking
  • Patients requiring legal representation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Revision Surgery
Time Frame: at least one timepoint at 8 months or more post-surgery
Rate of adverse events related to the Subject Device requiring surgical intervention.
at least one timepoint at 8 months or more post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Adverse Events
Time Frame: at least one timepoint at 8 months or more post-surgery
Intra-operative and post-operative adverse events (i.e., infection, CSF Leak, and Pseudomeningocele)
at least one timepoint at 8 months or more post-surgery
Product Performance
Time Frame: at least one timepoint at 8 months or more post-surgery
Score of adequacy of product performance - 1 (poor) to 4 (excellent)
at least one timepoint at 8 months or more post-surgery
Product Handling at Implantation
Time Frame: Initial surgery
Score for product handling at implantation - 1 (poor) to 4 (excellent)
Initial surgery
Product Adaptability at Implantation
Time Frame: Initial surgery
Score for product adaptability at implantation - 1 (poor) to 4 (excellent)
Initial surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collagen Matrix

Collaborators

Stryker Nordic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CIP.088

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Repair of Dura Mater

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe