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.
Female subjects ≥ 22 years of age.
First-time breast reconstruction post-mastectomy for target breast(s).
Scheduled to undergo unilateral or bilateral mastectomy with immediate, two-stage, implant-based, subpectoral or prepectoral breast reconstruction after mastectomy.
Mastectomy performed to address breast cancer or for cancer prophylaxis.
Subject has had a revision(s) in the target breast(s) following complications of breast augmentation, mastopexy (breast lift), or breast reduction.
Subject has undergone previous radiation therapy to the reconstruction site or chest wall.
Subject has had chemotherapy within 3 weeks prior to the index procedure.
Subject has been treated for a systemic infection or local infection at the surgical site within 30 days prior to index procedure.
Single group
TRBR Device
DeviceThe GORE® Tissue Reinforcement for Breast Reconstruction device is intended to reinforce the soft tissue surrounding the tissue expander in preparation for the breast implant in post-mastectomy breast reconstruction
Absence of device- or procedure-related major adverse events (MAEs)
Require rehospitalization or reoperation
BREAST-Q Physical Well Being
Chest Score change from baseline (pre-index procedure).
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W.L.Gore & Associates
Lead sponsor
Avania
Collaborator
