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 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.

NCT Number	NCT06556654
Lead Sponsor	W.L.Gore & Associates Collaborators: Avania
Conditions	Breast Reconstruction Surgery
Enrollment	180 participants
Start Date	2025-04-09
Primary Completion	2027-07 (estimated)
Study Completion	2030-07 (estimated)
Updated on ClinicalTrials.gov	2025-10-23