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Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Sep 2026 to Jul 2027
    • Study sites: 2 to 20
    • Study completion date: Sep 2029 to Jul 2030
    v5
  2. Start date changed from estimate of Apr 2025 to Apr 9, 2025v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 28, 2025 to Apr 2025
    • Study sites: 0 to 2
    v3
  4. Start date: Sep 2024 to Feb 28, 2025
    • Secondary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 4 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Treatment Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Control Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is investigational, which means it has not yet been used nor approved by the FDA for this treatment. The data collected in this study will be compared to the data collected in the Control Arm.
Trial Details
NCT Number NCT06556654
Lead Sponsor W.L.Gore & Associates
Collaborators: Avania
Conditions
(from sponsor)		 Breast Reconstruction Surgery
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov