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

October 21, 2025 updated by: W.L.Gore & Associates

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Arizona
        • Contact:
        • Principal Investigator:
          • William Casey III, MD
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
        • Principal Investigator:
          • Geoffrey Gurtner, MD, FACS
        • Contact:
    • California
      • Irvine, California, United States, 92697-7600
        • Not yet recruiting
        • The Regents of the University of California
        • Contact:
        • Principal Investigator:
          • Gordon Lee, MD
      • Los Angeles, California, United States, 90048
        • Not yet recruiting
        • Cedars-Sinai Plastic and Reconstruction Surgery
        • Contact:
        • Principal Investigator:
          • David Kulber, MD
      • Moreno Valley, California, United States, 92555
        • Recruiting
        • Riverside University Health System-Medical Center
        • Contact:
        • Principal Investigator:
          • Brian Eichenberg, MD, FACS
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Contact:
        • Principal Investigator:
          • Brian Rinker, MD
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Robert Galiano, MD
        • Contact:
      • Evanston, Illinois, United States, 60201-3137
        • Recruiting
        • Endeavor Health (Northshore University HealthSystem Research Institute)
        • Contact:
        • Principal Investigator:
          • Mark Sisco, MD
    • Kansas
      • Wichita, Kansas, United States, 67206
        • Recruiting
        • BR Hope LLC
        • Contact:
        • Principal Investigator:
          • Therese Cusick, MD
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • The Johns Hopkins University
        • Principal Investigator:
          • Damon Cooney, MD, PhD
        • Contact:
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Research Institute
        • Contact:
        • Principal Investigator:
          • Ronald Ford, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin McIntyre, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5331
        • Recruiting
        • The Board of Regents of the University of Nebraska
        • Contact:
        • Principal Investigator:
          • Heidi Hon, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • The Joan and Sanford I. Weill Medical College of Cornell University
        • Contact:
        • Principal Investigator:
          • David Otterburn, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • The Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Risal Djohan, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • The Fox Chase Cancer Center
        • Contact:
        • Principal Investigator:
          • Sameer Patel, MD, FACS
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • The University of Washington Medical Center
        • Contact:
        • Principal Investigator:
          • Louie Otway, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • The Board of Regents of the University of Wisconsin System
        • Principal Investigator:
          • Samuel Poore, MD, PhD
        • Contact:
        • Contact:
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • The Medical College of Wisconsin, Inc.
        • Contact:
        • Principal Investigator:
          • John LoGiudice, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female subjects ≥ 22 years of age.
  2. First-time breast reconstruction post-mastectomy for target breast(s).
  3. Scheduled to undergo unilateral or bilateral mastectomy with immediate, two-stage, implant-based, subpectoral or prepectoral breast reconstruction after mastectomy.
  4. Mastectomy performed to address breast cancer or for cancer prophylaxis.
  5. An informed consent form is signed by Subject or Legally Authorized Representative (LAR).
  6. Subject is capable of following protocol procedures and complying with follow-up visit requirements

Exclusion Criteria:

Baseline Exclusion Criteria

  1. Subject has had a revision(s) in the target breast(s) following complications of breast augmentation, mastopexy (breast lift), or breast reduction.
  2. Subject has undergone previous radiation therapy to the reconstruction site or chest wall.
  3. Subject has had chemotherapy within 3 weeks prior to the index procedure.
  4. Subject has been treated for a systemic infection or local infection at the surgical site within 30 days prior to index procedure.
  5. Subject has a current or previous diagnosis of Methicillin-resistant Staphylococcus aureus (MRSA).
  6. Subject has a BMI > 35.
  7. Subject has a known diagnosis of diabetes with a HbA1c > 7.0mmol/L within 30 days of the Index procedure (i.e., TE placement).
  8. Subject was a current or former tobacco/nicotine user, within 90 days prior to Index Surgery (i.e., TE placement).
  9. 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.
  10. Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
  11. 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.
  12. Subject requires a surgical technique requiring flap (autologous tissue).
  13. 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
  14. 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).
  15. Subject receives an Acellular Dermal Matrix (ADM) or mesh that is not the TRBR Device in the target breast(s)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prospective Arm
Prospectively treated subjects who undergo two-stage implant-based breast reconstruction with the TRBR Device (TRBR Device group)
Device: TRBR 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absence of device- or procedure-related major adverse events (MAEs)
Time Frame: 1 year post index procedure
Require rehospitalization or reoperation
1 year post index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BREAST-Q Physical Well Being
Time Frame: 1-year post-index procedure.
Chest Score change from baseline (pre-index procedure).
1-year post-index procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
W.L.Gore & Associates

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Avania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dennis Hammond, MD, Partners in Plastic Surgery of West Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TBR 22-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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