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

NCT06556654 | Recruiting DMC FDA Device

• 1 other identifier: TBR 22-07
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Breast Reconstruction Surgery

Keywords

breast reconstruction; post-mastectomy; tissue expander; implant based breast reconstruction; two-stage; immediate; subpectoral; prepectoral

Outcome Measures

Primary Outcomes (1)

• Absence of device- or procedure-related major adverse events (MAEs)

  Require rehospitalization or reoperation

  1 year post index procedure

Secondary Outcomes (1)

• BREAST-Q Physical Well Being

  1-year post-index procedure.

Study Arms (1)

Prospective Arm

EXPERIMENTAL

Prospectively treated subjects who undergo two-stage implant-based breast reconstruction with the TRBR Device (TRBR Device group)

Device: TRBR Device

Interventions

TRBR Device DEVICE

The 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

Prospective Arm

Eligibility Criteria

• Age: 22 Years+
• Gender Eligibility Details: Female at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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).
• 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)

Sponsors & Collaborators

• W.L.Gore & Associates: lead
• Avania: collaborator

Study Sites (20)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

The Regents of the University of California

Irvine, California, 92697-7600, United States

NOT YET RECRUITING

Cedars-Sinai Plastic and Reconstruction Surgery

Los Angeles, California, 90048, United States

NOT YET RECRUITING

Riverside University Health System-Medical Center

Moreno Valley, California, 92555, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Endeavor Health (Northshore University HealthSystem Research Institute)

Evanston, Illinois, 60201-3137, United States

RECRUITING

Northwestern University

Evanston, Illinois, 60208, United States

RECRUITING

BR Hope LLC

Wichita, Kansas, 67206, United States

RECRUITING

The Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

Corewell Health Research Institute

Grand Rapids, Michigan, 49503, United States

RECRUITING

University of Mississippi

Jackson, Mississippi, 39216, United States

RECRUITING

The Board of Regents of the University of Nebraska

Omaha, Nebraska, 68198-5331, United States

RECRUITING

The Joan and Sanford I. Weill Medical College of Cornell University

New York, New York, 10065, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

The Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

The University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

The Board of Regents of the University of Wisconsin System

Madison, Wisconsin, 53715, United States

RECRUITING

The Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Study Officials

• Dennis Hammond, MD

  Partners in Plastic Surgery of West Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariana O'Neill

CONTACT

1 800-437-8181; TBR22-07@wlgore.com

Mary Wexler

CONTACT

1 800-437-8181; TBR22-07@wlgore.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a investigational, multi-center, single-arm pivotal study to review safety outcomes of prospectively treated subjects who underwent two-stage implant-based breast reconstruction with the TRBR Device (TRBR Device group) to control subjects who underwent two-stage implant-based breast reconstruction with no mesh/ADM (Control group). Effectiveness of TRBR will be evaluated by comparing change from baseline (pre-index procedure) at 1-year post-index procedure in BREAST-Q.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 16, 2024
• Study Start: April 9, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2030
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)