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NCT Number: NCT07371091

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

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

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Key information

Conditions

Repair of Dura Mater

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rush University Medical Center, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. Product Handling at Implantation

    Time frame: Initial surgery

    Score for product handling at implantation - 1 (poor) to 4 (excellent)

  4. Product Adaptability at Implantation

    Time frame: Initial surgery

    Score for product adaptability at implantation - 1 (poor) to 4 (excellent)

Study contacts

Contact information is provided by the study sponsor or research team.

Meenakshi Paliwal

CONTACT

[email protected]

347-439-1634

Sarah Grace Dennis-Little, PhD

CONTACT

[email protected]

706-247-0251

Sponsors and collaborators

Lead sponsor

Collagen Matrix

Industry

Collaborators

  • Stryker Nordic

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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