Clinical Investigation Plan - Post-market Clinical Follow-up Study Collagen Dura Membrane - Suturable

Part of paid clinical trials in Miami, Florida.

Sponsor
Collagen Matrix
Study ID
NCT07217132
Status
Not Yet 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 Dura Membrane - Suturable (DMS) in the post-market phase

Key Dates

Start date
Dec 1, 2025
Status verified
Oct 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
54 participants (estimated)

Primary Outcome Measure

Rate of Adverse Events Requiring Surgical Intervention [ Time Frame: 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baptist Health South FloridaMiamiFlorida33176
Starlie Belnap, PhD
7865961825
Michael W McDermott, MD (PRINCIPAL_INVESTIGATOR)

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