Actively Recruiting
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
Led by W.L.Gore & Associates · Updated on 2025-10-23
180
Participants Needed
20
Research Sites
272 weeks
Total Duration
On this page
Sponsors
W
W.L.Gore & Associates
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects 22 years of age or older
- First-time breast reconstruction after mastectomy for the target breast(s)
- Scheduled for unilateral or bilateral mastectomy with immediate, two-stage, implant-based, subpectoral or prepectoral breast reconstruction
- Mastectomy performed for breast cancer treatment or cancer prevention
- Signed informed consent by subject or legally authorized representative
- Ability to follow study procedures and attend follow-up visits
You will not qualify if you...
- Previous revision surgery on target breast(s) due to complications from augmentation, breast lift, or breast reduction
- Prior radiation therapy to the reconstruction site or chest wall
- Chemotherapy within 3 weeks before the index procedure
- Treatment for systemic or local infection at surgical site within 30 days before index procedure
- Current or previous diagnosis of Methicillin-resistant Staphylococcus aureus (MRSA)
- Body mass index (BMI) over 35
- Diabetes with HbA1c greater than 7.0 mmol/L within 30 days before index procedure
- Tobacco or nicotine use within 90 days before index surgery
- Use of medications that may increase risk of complications, such as systemic steroids
- Medical, social, or psychological conditions interfering with consent, testing, therapy, or follow-up
- Participation in another investigational drug, biologic, or device study that may interfere with this study
- Need for surgical techniques using flap (autologous tissue)
- Pregnancy or breastfeeding at time of index procedure or planning pregnancy before exchange procedure
- Unsuitable tissue integrity for immediate two-stage breast reconstruction per investigator
- Use of Acellular Dermal Matrix (ADM) or mesh other than the TRBR Device in target breast(s)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
3
The Regents of the University of California
Irvine, California, United States, 92697-7600
Not Yet Recruiting
4
Cedars-Sinai Plastic and Reconstruction Surgery
Los Angeles, California, United States, 90048
Not Yet Recruiting
5
Riverside University Health System-Medical Center
Moreno Valley, California, United States, 92555
Actively Recruiting
6
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
7
Endeavor Health (Northshore University HealthSystem Research Institute)
Evanston, Illinois, United States, 60201-3137
Actively Recruiting
8
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
9
BR Hope LLC
Wichita, Kansas, United States, 67206
Actively Recruiting
10
The Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
11
Corewell Health Research Institute
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
12
University of Mississippi
Jackson, Mississippi, United States, 39216
Actively Recruiting
13
The Board of Regents of the University of Nebraska
Omaha, Nebraska, United States, 68198-5331
Actively Recruiting
14
The Joan and Sanford I. Weill Medical College of Cornell University
New York, New York, United States, 10065
Actively Recruiting
15
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
16
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
17
The Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
18
The University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
19
The Board of Regents of the University of Wisconsin System
Madison, Wisconsin, United States, 53715
Actively Recruiting
20
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
A
Ariana O'Neill
CONTACT
M
Mary Wexler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here