Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

Recruiting now · Not applicable

Conditions studied: Breast Reconstruction Surgery

In brief

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 facts

Study ID

NCT06556654

Run by

W.L.Gore & Associates

People needed

180

Starts

2025-04-09

Expected to finish

2030-07-01

Last updated by the study team

2025-10-23

Who can join

Age: 22 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• An informed consent form is signed by Subject or Legally Authorized Representative (LAR).
• Subject is capable of following protocol procedures and complying with follow-up visit requirements

You may not qualify if…

• Baseline Exclusion Criteria
• 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.
• Subject has a current or previous diagnosis of Methicillin-resistant Staphylococcus aureus (MRSA).
• Subject has a BMI > 35.
• Subject has a known diagnosis of diabetes with a HbA1c > 7.0mmol/L within 30 days of the Index procedure (i.e., TE placement).
• Subject was a current or former tobacco/nicotine user, within 90 days prior to Index Surgery (i.e., TE placement).
• Subject is currently taking medication (e.g., systemic steroid), which in the investigator's opinion, may increase the risk of local complications of breast reconstruction.
• Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
• Subject is currently participating in or planning to participate in another investigational drug, biologic or medical device study that may interfere with compliance of TBR 22-07 study requirements or may confound TBR 22-07 study data/outcomes.
• Subject requires a surgical technique requiring flap (autologous tissue).
• Subject is pregnant or lactating at the time of the index procedure (i.e., TE placement) or is planning to become pregnant prior to the Exchange procedure. Intraoperative Index Procedure Exclusion
• Based on investigator's opinion, subject has unsuitable tissue integrity for immediate 2-stage breast reconstruction or is no longer a candidate to receive the TRBR Device (will be recorded as a screen failure).
• Subject receives an Acellular Dermal Matrix (ADM) or mesh that is not the TRBR Device in the target breast(s)

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
• University of Arizona — Tucson, Arizona, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• The Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• The University of Washington Medical Center — Seattle, Washington, United States (enrolling)
• The Board of Regents of the University of Wisconsin System — Madison, Wisconsin, United States (enrolling)
• Riverside University Health System-Medical Center — Moreno Valley, California, United States (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• Endeavor Health (Northshore University HealthSystem Research Institute) — Evanston, Illinois, United States (enrolling)
• Northwestern University — Evanston, Illinois, United States (enrolling)
• BR Hope LLC — Wichita, Kansas, United States (enrolling)
• The Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Corewell Health Research Institute — Grand Rapids, Michigan, United States (enrolling)
• University of Mississippi — Jackson, Mississippi, United States (enrolling)
• The Board of Regents of the University of Nebraska — Omaha, Nebraska, United States (enrolling)
• The Joan and Sanford I. Weill Medical College of Cornell University — New York, New York, United States (enrolling)
• The Regents of the University of California — Irvine, California, United States
• Cedars-Sinai Plastic and Reconstruction Surgery — Los Angeles, California, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Medical College of Wisconsin, Inc. — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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