Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
Scottsdale/Phoenix, AZ; Jacksonville, FL
This record is for the Prospective treatment arm, the Retrospective cohort will have a seperate protocol and IRBe record.
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 Prospective Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Retrospective 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 ...