Condition: Breast Reconstruction Surgery · Sponsor: W.L.Gore & Associates
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.
This description comes directly from the study's public registry record.
Ariana O'Neill · 1 800-437-8181 · TBR22-07@wlgore.com
Mary Wexler · 1 800-437-8181 · TBR22-07@wlgore.com
Always discuss trial participation with your own doctor first.
| Mayo Clinic Arizona | Scottsdale, Arizona, United States | Recruiting |
| University of Arizona | Tucson, Arizona, United States | Recruiting |
| The Regents of the University of California | Irvine, California, United States | Not Yet Recruiting |
| Cedars-Sinai Plastic and Reconstruction Surgery | Los Angeles, California, United States | Not Yet Recruiting |
| Riverside University Health System-Medical Center | Moreno Valley, California, United States | Recruiting |
| Mayo Clinic Florida | Jacksonville, Florida, United States | Recruiting |
| Endeavor Health (Northshore University HealthSystem Research Institute) | Evanston, Illinois, United States | Recruiting |
| Northwestern University | Evanston, Illinois, United States | Recruiting |
| BR Hope LLC | Wichita, Kansas, United States | Recruiting |
| The Johns Hopkins University | Baltimore, Maryland, United States | Recruiting |
| Corewell Health Research Institute | Grand Rapids, Michigan, United States | Recruiting |
| University of Mississippi | Jackson, Mississippi, United States | Recruiting |
+ 8 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06556654