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

Join a study on DuraMatrix-Onlay Plus for dural repair.

Recruiting
18 years and older
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

Study Overview: This study is about watching how a medical product called Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) works after it has been approved for use. The product helps fix the dura mater, a tough tissue covering your brain and spine. This study will take place at up to 8 different locations and will include 118 people.

Key Details:

  • The study checks if anyone needs another surgery after using the product.
  • Doctors will look for any problems like fluid leaks (CSF leak), infections, or a condition called Pseudomeningocele during follow-ups.
  • You'll have a check-up at least 8 weeks after your surgery.

Privacy: Your personal details won't be shared with the company making the product.

Eligibility: Anyone needing a dura mater repair can join, unless their condition doesn't fit the product's usage rules.

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Study details
    Repair of Dura Mater

NCT06802133

Collagen Matrix

7 March 2026

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