Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- W.L.Gore & Associates
- Study ID
- NCT06556654
- Status
- Recruiting
Conditions
- Breast Reconstruction Surgery
Eligibility Criteria
- Sex
- FEMALE
- Age
- 22 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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
Study Details
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.
Key Dates
- Start date
- Apr 9, 2025
- Status verified
- Oct 2025
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2030
Study Design
- Enrollment
- 180 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Prospective ArmProspectively treated subjects who undergo two-stage implant-based breast reconstruction with the TRBR Device (TRBR Device group)
Primary Outcome Measure
Absence of device- or procedure-related major adverse events (MAEs) [ Time Frame: 1 year post index procedure ]
Central Contacts
- Ariana O'Neill1 800-437-8181
- Mary Wexler1 800-437-8181
Locations (20)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | William Casey III, MD (PRINCIPAL_INVESTIGATOR) |
| University of Arizona | Tucson | Arizona | 85724 | Geoffrey Gurtner, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| The Regents of the University of California | Irvine | California | 92697-7600 | Gordon Lee, MD (PRINCIPAL_INVESTIGATOR) |
| Cedars-Sinai Plastic and Reconstruction Surgery | Los Angeles | California | 90048 | David Kulber, MD (PRINCIPAL_INVESTIGATOR) |
| Riverside University Health System-Medical Center | Moreno Valley | California | 92555 | Brian Eichenberg, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Brian Rinker, MD (PRINCIPAL_INVESTIGATOR) |
| Endeavor Health (Northshore University HealthSystem Research Institute) | Evanston | Illinois | 60201-3137 | Mark Sisco, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern University | Evanston | Illinois | 60208 | Robert Galiano, MD (PRINCIPAL_INVESTIGATOR) |
| BR Hope LLC | Wichita | Kansas | 67206 | Therese Cusick, MD (PRINCIPAL_INVESTIGATOR) |
| The Johns Hopkins University | Baltimore | Maryland | 21205 | Damon Cooney, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Corewell Health Research Institute | Grand Rapids | Michigan | 49503 | Ronald Ford, MD (PRINCIPAL_INVESTIGATOR) |
| University of Mississippi | Jackson | Mississippi | 39216 | Benjamin McIntyre, MD (PRINCIPAL_INVESTIGATOR) |
| The Board of Regents of the University of Nebraska | Omaha | Nebraska | 68198-5331 | Heidi Hon, MD (PRINCIPAL_INVESTIGATOR) |
| The Joan and Sanford I. Weill Medical College of Cornell University | New York | New York | 10065 | David Otterburn, MD (PRINCIPAL_INVESTIGATOR) |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Risal Djohan, MD (PRINCIPAL_INVESTIGATOR) |
| The Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | Sameer Patel, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Said Azoury, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Washington Medical Center | Seattle | Washington | 98195 | Louie Otway, MD (PRINCIPAL_INVESTIGATOR) |
| The Board of Regents of the University of Wisconsin System | Madison | Wisconsin | 53715 | Nura Said Samuel Poore, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| The Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | 53226 | John LoGiudice, MD (PRINCIPAL_INVESTIGATOR) |