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Study identifier: NCT06556654 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Breast Reconstruction Surgery  ·  Sponsor: W.L.Gore & Associates

PhaseNA
Planned participants180
Who can joinFemale, 22 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Ariana O'Neill  ·  1 800-437-8181  ·  TBR22-07@wlgore.com

Mary Wexler  ·  1 800-437-8181  ·  TBR22-07@wlgore.com

Always discuss trial participation with your own doctor first.

Locations (20)

Mayo Clinic ArizonaScottsdale, Arizona, United StatesRecruiting
University of ArizonaTucson, Arizona, United StatesRecruiting
The Regents of the University of CaliforniaIrvine, California, United StatesNot Yet Recruiting
Cedars-Sinai Plastic and Reconstruction SurgeryLos Angeles, California, United StatesNot Yet Recruiting
Riverside University Health System-Medical CenterMoreno Valley, California, United StatesRecruiting
Mayo Clinic FloridaJacksonville, Florida, United StatesRecruiting
Endeavor Health (Northshore University HealthSystem Research Institute)Evanston, Illinois, United StatesRecruiting
Northwestern UniversityEvanston, Illinois, United StatesRecruiting
BR Hope LLCWichita, Kansas, United StatesRecruiting
The Johns Hopkins UniversityBaltimore, Maryland, United StatesRecruiting
Corewell Health Research InstituteGrand Rapids, Michigan, United StatesRecruiting
University of MississippiJackson, Mississippi, United StatesRecruiting

+ 8 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06556654