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NCT06556654 · ClinicalTrials.gov registry record · NA
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
A NA study of Breast Reconstruction Surgery, sponsored by W.L.Gore & Associates.
- Recruiting
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT06556654 is a NA study of Breast Reconstruction Surgery that is actively recruiting participants, run by W.L.Gore & Associates. The registered enrollment target is 180 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT06556654, a NA study of Breast Reconstruction Surgery, is actively recruiting participants, sponsored by W.L.Gore & Associates.
- RECRUITING
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE TRBR Device
Study Locations (20)
California
- The Regents of the University of California - Irvine
- Cedars-Sinai Plastic and Reconstruction Surgery - Los Angeles
- Riverside University Health System-Medical Center - Moreno Valley
Arizona
- Mayo Clinic Arizona - Scottsdale
- University of Arizona - Tucson
Illinois
- Endeavor Health (Northshore University HealthSystem Research Institute) - Evanston
- Northwestern University - Evanston
Pennsylvania
- University of Pennsylvania - Philadelphia
- The Fox Chase Cancer Center - Philadelphia
Wisconsin
- The Board of Regents of the University of Wisconsin System - Madison
- The Medical College of Wisconsin, Inc. - Milwaukee
Florida
- Mayo Clinic Florida - Jacksonville
Kansas
- BR Hope LLC - Wichita
Maryland
- The Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2025-04-09 |
| Est. Completion | 2030-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06556654
The ClinicalTrials.gov registry entry for NCT06556654 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is W.L.Gore & Associates, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Reconstruction Surgery appearing as the primary indexed condition, and to 1 intervention - of which TRBR Device is the first listed.
NCT06556654 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Arizona, Illinois.
Frequently Asked Questions
What is clinical trial NCT06556654 about?
NCT06556654 is a clinical study titled "Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)". 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 Recon...
What is the current status of trial NCT06556654?
This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2025-04-09. Estimated completion is 2030-07.
What conditions does trial NCT06556654 study?
This clinical trial studies the following conditions: Breast Reconstruction Surgery.
What interventions are being tested in trial NCT06556654?
The interventions under investigation include: TRBR Device (DEVICE).
Who is sponsoring clinical trial NCT06556654?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06556654 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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