Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE) (NCT06556654)
Evaluation of the Safety and Effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction Device (TRBR Device) When Used in the Reinforcement of Breast Reconstruction
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Arizona — Scottsdale, Arizona
Age range: 22 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- Mayo Clinic Arizona — Scottsdale, Arizona
- University of Arizona — Tucson, Arizona
- The Regents of the University of California — Irvine, California
- Cedars-Sinai Plastic and Reconstruction Surgery — Los Angeles, California
- Riverside University Health System-Medical Center — Moreno Valley, California
- Mayo Clinic Florida — Jacksonville, Florida
- Endeavor Health (Northshore University HealthSystem Research Institute) — Evanston, Illinois
- Northwestern University — Evanston, Illinois
- BR Hope LLC — Wichita, Kansas
- The Johns Hopkins University — Baltimore, Maryland
- Corewell Health Research Institute — Grand Rapids, Michigan
- University of Mississippi — Jackson, Mississippi
- The Board of Regents of the University of Nebraska — Omaha, Nebraska
- The Joan and Sanford I. Weill Medical College of Cornell University — New York, New York
- The Cleveland Clinic Foundation — Cleveland, Ohio
- University of Pennsylvania — Philadelphia, Pennsylvania
- The Fox Chase Cancer Center — Philadelphia, Pennsylvania
- The University of Washington Medical Center — Seattle, Washington
- The Board of Regents of the University of Wisconsin System — Madison, Wisconsin
- The Medical College of Wisconsin, Inc. — Milwaukee, Wisconsin
📞 Contact the Study Coordinator
Phone: (800) 437-8181
Email: TBR22-07@wlgore.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Breast Reconstruction Surgery clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.