Study Summary

The purpose of the study is to evaluate the safety and effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction (TRBR) Device. This investigational device is designed to support soft tissue during two-stage, implant-based breast reconstruction following mastectomy. The study includes two groups: a treatment group receiving the TRBR Device during surgery, and a control group consisting of patients who previously underwent similar procedures without any additional tissue reinforcement. Researchers aim to assess whether the TRBR Device reduces major adverse events and improves physical well-being, using measures like the BREAST-Q score over one year. The study is currently recruiting participants across multiple U.S. sites, with an estimated enrollment of 180 subjects.

Protocol: 24-1062 / IRB24-1062

Investigator: Sameer Patel, MD, FACS

Disease(s): Breast

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Inclusion Criteria:

1. Female patient must be older than 22 years of age who is scheduled to undergo unilateral or bilateral mastectomy with immediate, two-stage, implant-based, subpectoral or prepectoral breast reconstruction after mastectomy for breast cancer or prophylaxis.
2. Patient must be a first-time breast reconstruction post-mastectomy for target breast(s).
3. Patient must not have had any revision(s) to the target breast following complications from breast augmentation, mastopexy, or breast reductions .
4. Patient must not have a BMI greater than 35.
5. Patient must not have received prior radiation to the area/chest wall or undergone chemotherapy in the 3 weeks prior to surgery.
6. Patient must have no history of MRSA or currently being treated for a systemic infection or local infection. 

For more information about this and other studies and to inquire about eligibility, please call 215-214-1515.