Study of the Safety and Effectiveness of the GORE Tissue Reinforcement Device for Breast Reconstruction After Mastectomy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the GORE Tissue Reinforcement for Breast Reconstruction TRBR Device in women undergoing breast reconstruction after mastectomy. This study compares data collected from women receiving the investigational TRBR Device during two-stage implant-based breast reconstruction with data from women who previously had similar surgeries without additional tissue reinforcement. The study aims to assess safety and the success of breast reconstruction using this new device, which has not yet been approved by the FDA for this use. Participants in the Treatment Arm will receive the TRBR Device, which is designed to reinforce the soft tissue around the tissue expander before placing the breast implant after mastectomy. The device is used during immediate, two-stage implant-based breast reconstruction, either under the pectoral muscle subpectoral or above it prepectoral. The Control Arm includes data from subjects who had reconstruction without the device. This study includes women having unilateral or bilateral mastectomy for breast cancer treatment or prevention. During the study, participants will be monitored for major adverse events related to the device or procedure for one year after the initial surgery. Researchers will also assess physical well-being using the BREAST-Q questionnaire at one year post-procedure. Participants must comply with follow-up visits and protocol procedures. The study will continue until July 2030, with close observation of device safety and reconstruction outcomes.

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