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NCT Number: NCT06802133

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.

Recruiting

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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

Augusta University, Augusta, Georgia, United States

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About this study

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.

Who can participate

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

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.

Treatment and study plan

Post Market Study

Other

Prospective case series without a concurrent comparator group.

Primary outcomes

  1. Rate of Revision Surgery

    Time frame: 8 weeks

    Adequate healing of dural defects without need for a revision surgery or second intervention

Secondary outcomes

  1. Rate of Adverse events

    Time frame: 8 weeks

    Rate of product-related adverse events or complications

Study contacts

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

Meenakshi Paliwal

CONTACT

[email protected]

2014051477 ext. 324

Peggy Hansen

CONTACT

[email protected]

201-405-1477 ext. 304

Sponsors and collaborators

Lead sponsor

Collagen Matrix

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2025
Registry last updated
Oct 15, 2025

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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