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

ClinicalTrials.gov ID: NCT06556654

Public ClinicalTrials.gov record NCT06556654. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 23, 2026, 6:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of the Safety and Effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction Device (TRBR Device) When Used in the Reinforcement of Breast Reconstruction

Study identification

NCT ID: NCT06556654
Recruitment status: Recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: W.L.Gore & Associates; Industry
Enrollment: 180 participants

Conditions and interventions

Conditions

Breast Reconstruction Surgery

Interventions

TRBR Device Device

Device

Eligibility (public fields only)

Age range: 22 Years and older
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 8, 2025
Primary completion: Jun 30, 2027
Completion: Jun 30, 2030
Last update posted: Oct 22, 2025

2025 – 2030

United States locations

U.S. sites: 20
U.S. states: 14
U.S. cities: 18

Facility	City	State	ZIP	Site status
Mayo Clinic Arizona	Scottsdale	Arizona	85259	Recruiting
University of Arizona	Tucson	Arizona	85724	Recruiting
The Regents of the University of California	Irvine	California	92697-7600	Not yet recruiting
Cedars-Sinai Plastic and Reconstruction Surgery	Los Angeles	California	90048	Not yet recruiting
Riverside University Health System-Medical Center	Moreno Valley	California	92555	Recruiting
Mayo Clinic Florida	Jacksonville	Florida	32224	Recruiting
Endeavor Health (Northshore University HealthSystem Research Institute)	Evanston	Illinois	60201-3137	Recruiting
Northwestern University	Evanston	Illinois	60208	Recruiting
BR Hope LLC	Wichita	Kansas	67206	Recruiting
The Johns Hopkins University	Baltimore	Maryland	21205	Recruiting
Corewell Health Research Institute	Grand Rapids	Michigan	49503	Recruiting
University of Mississippi	Jackson	Mississippi	39216	Recruiting
The Board of Regents of the University of Nebraska	Omaha	Nebraska	68198-5331	Recruiting
The Joan and Sanford I. Weill Medical College of Cornell University	New York	New York	10065	Recruiting
The Cleveland Clinic Foundation	Cleveland	Ohio	44195	Not yet recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Recruiting
The Fox Chase Cancer Center	Philadelphia	Pennsylvania	19111	Recruiting
The University of Washington Medical Center	Seattle	Washington	98195	Recruiting
The Board of Regents of the University of Wisconsin System	Madison	Wisconsin	53715	Recruiting
The Medical College of Wisconsin, Inc.	Milwaukee	Wisconsin	53226	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06556654, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 22, 2025 · Synced Jul 23, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06556654 live on ClinicalTrials.gov.

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