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Breast Reconstruction SurgeryNCT06556654

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

A study testing TRBR Device in people with Breast Reconstruction Surgery, run by W.L.Gore & Associates at 20 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 22 years and older, women only
Conditions the study is for
Breast Reconstruction Surgery
What is being tested?
TRBR Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
20 sitesUnited States
Study dates
9 Apr 2025to Jul 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 16Show fewer
  • 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)

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ariana O'Neill contact

1 800-437-8181

TBR22-07@wlgore.com

Mary Wexler contact

1 800-437-8181

TBR22-07@wlgore.com

20 sites in 1 country

United States20 sites, 20 recruiting

  • The Johns Hopkins University

    Baltimore, Maryland, 21205

    Carisa Cooney, 443-287-4629, ccooney3@jhmi.edu

    Damon Cooney, MD, PhD

    Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Rothy Rim, 216-444-7277, RIMR@ccf.org

    Risal Djohan, MD

    Not yet recruiting

  • Endeavor Health (Northshore University HealthSystem Research Institute)

    Evanston, Illinois, 60201-3137

    Riley Medenwald, 847-570-3944, rmedenwald@northshore.org

    Mark Sisco, MD

    Recruiting

  • Northwestern University

    Evanston, Illinois, 60208

    Anna Whitney, 312-695-5674, anna.whitney@nm.org

    Robert Galiano, MD

    Recruiting

  • Corewell Health Research Institute

    Grand Rapids, Michigan, 49503

    Megan Kruizenga, 616-502-5571, megan.kruizenga@corewellhealth.org

    Ronald Ford, MD

    Recruiting

  • The Regents of the University of California

    Irvine, California, 92697-7600

    Anthony Warner, 714-456-7890, acwarner@hs.uci.edu

    Gordon Lee, MD

    Not yet recruiting

  • University of Mississippi

    Jackson, Mississippi, 39216

    Eldrin Eldrin Bhanat, 601-815-1568, ebhanat@umc.edu

    Laxmi Laxmi Dhungel, (601) 984-5075, ldhungel@umc.edu

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Franky LoCascio, 904-953-4024, LoCascio.Frank@mayo.edu

    Brian Rinker, MD

    Recruiting

  • Cedars-Sinai Plastic and Reconstruction Surgery

    Los Angeles, California, 90048

    Michael Fernandez, 310-423-2129, michael.fernandez2@cshs.org

    David Kulber, MD

    Not yet recruiting

  • The Board of Regents of the University of Wisconsin System

    Madison, Wisconsin, 53715

    Nicole Byington, 608-265-6858, byington@surgery.wisc.edu

    Nura Said, said@surgery.wisc.edu

    Recruiting

  • The Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226

    Krissa Packard, 414-955-1861, kpackard@mcw.edu

    John LoGiudice, MD

    Not yet recruiting

  • Riverside University Health System-Medical Center

    Moreno Valley, California, 92555

    Ana Lopez, 951-486-7610, ana.lopez@ruhealth.org

    Brian Eichenberg, MD, FACS

    Recruiting

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

    New York, New York, 10065

    Ananya Sen, 646-962-6445, ase4003@med.cornell.edu

    David Otterburn, MD

    Recruiting

  • The Board of Regents of the University of Nebraska

    Omaha, Nebraska, 68198-5331

    Jaicy Omega, 402-559-0488, jaicy.omega@unmc.edu

    Heidi Hon, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Robyn Broach, 215-662-7300, Robyn.broach@pennmedicine.upenn.edu

    Said Azoury, MD

    Recruiting

  • The Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Erin Stratton, 215-728-4784, Erin.Stratton@fccc.edu

    Sameer Patel, MD, FACS

    Recruiting

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

    Debbie Ryan, 480-342-1208, ryan.debra29@mayo.edu

    William Casey III, MD

    Recruiting

  • The University of Washington Medical Center

    Seattle, Washington, 98195

    Alex Ruiz, 206-221-3883, aruiz06@uw.edu

    Louie Otway, MD

    Recruiting

  • University of Arizona

    Tucson, Arizona, 85724

    Fleur Maturo, 520-621-8296, fleurmartinez@arizona.edu

    Geoffrey Gurtner, MD, FACS

    Recruiting

  • BR Hope LLC

    Wichita, Kansas, 67206

    Sherri Newlin, 316-263-2013, sherrinewlin88@gmail.com

    Therese Cusick, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
TRBR Device
Keywords
breast reconstruction, post-mastectomy, tissue expander, implant based breast reconstruction, two-stage, immediate, subpectoral, prepectoral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRBR DeviceDevice

    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

Study groups in NCT06556654
Study groupRoleWhat they receive
Prospective ArmExperimentalProspectively treated subjects who undergo two-stage implant-based breast reconstruction with the TRBR Device (TRBR Device group)
Receives: Device: TRBR Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Require rehospitalization or reoperation

    Measured: 1 year post index procedure

Secondary outcomes (1)

  1. BREAST-Q Physical Well Being

    Chest Score change from baseline (pre-index procedure).

    Measured: 1-year post-index procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2024
  2. Study start9 Apr 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06556654
Sponsor's protocol ID
TBR 22-07
Status last verified
Oct 2025
First submitted
16 Jul 2024
Last updated
23 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TRBR Device in people with Breast Reconstruction Surgery, run by W.L.Gore & Associates at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ariana O'Neill (1 800-437-8181, TBR22-07@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence of device- or procedure-related major adverse events (MAEs) (time frame: 1 year post index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06556654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.

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