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New device aims to improve breast reconstruction safety

NCT ID NCT06556654

Disease control Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medical device designed to reinforce breast reconstruction surgery after mastectomy. About 180 women having their first breast reconstruction will be enrolled, with some receiving the device and others having standard surgery without it. The goal is to see if the device reduces complications like hospital readmission or repeat surgery, and improves chest well-being.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast reconstruction surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BR Hope LLC

    RECRUITING

    Wichita, Kansas, 67206, United States

  • Cedars-Sinai Plastic and Reconstruction Surgery

    NOT_YET_RECRUITING

    Los Angeles, California, 90048, United States

  • Corewell Health Research Institute

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Endeavor Health (Northshore University HealthSystem Research Institute)

    RECRUITING

    Evanston, Illinois, 60201-3137, United States

  • Mayo Clinic Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Northwestern University

    RECRUITING

    Evanston, Illinois, 60208, United States

  • Riverside University Health System-Medical Center

    RECRUITING

    Moreno Valley, California, 92555, United States

  • The Board of Regents of the University of Nebraska

    RECRUITING

    Omaha, Nebraska, 68198-5331, United States

  • The Board of Regents of the University of Wisconsin System

    RECRUITING

    Madison, Wisconsin, 53715, United States

  • The Cleveland Clinic Foundation

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • The Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

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

    RECRUITING

    New York, New York, 10065, United States

  • The Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • The Medical College of Wisconsin, Inc.

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • The Regents of the University of California

    NOT_YET_RECRUITING

    Irvine, California, 92697-7600, United States

  • The University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of Mississippi

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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