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

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Collagen Matrix
Study ID
NCT06802133
Status
Recruiting
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Conditions

  • Repair of Dura Mater

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Post Market Study — OTHER
    Prospective case series without a concurrent comparator group.

Study Details

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

Key Dates

Start date
Jan 13, 2025
Status verified
Oct 2025
Primary completion
May 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
118 participants (estimated)

Primary Outcome Measure

Rate of Revision Surgery [ Time Frame: 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Augusta UniversityAugustaGeorgia30912
Candelario Laserna, MD
[email protected]
Natasha Flores
[email protected]
Scott Rahimi, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Sophie A Munn
[email protected]
Erica Fox
[email protected]
Brian Nahed, MD (PRINCIPAL_INVESTIGATOR)

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