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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: Recruiting NA study of Breast Reconstruction Surgery, sponsored by W.L.Gore & Associates.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Require rehospitalization or reoperation
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 |
What NCT06556654 shows while recruiting
NCT06556654 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06556654's enrollment target sits among peer trials
180 586th of 2000 higher than 1,397 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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