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New device for breast reconstruction after mastectomy

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

Not applicable Interventional W.L.Gore & Associates · NCT06556654

This study is testing a new device to see if it can improve breast reconstruction results for women who have had a mastectomy.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment180 (estimated)
Ages22 Years and up
SexFemale
SponsorW.L.Gore & Associates Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations20 sites (Scottsdale, Arizona and 19 other locations)
Trial IDNCT06556654 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of a new medical device, the Tissue Reinforcement for Breast Reconstruction (TRBR) Device, during breast reconstruction surgeries following mastectomy. Participants will be divided into two groups: one receiving the TRBR Device and the other serving as a control group who have undergone similar surgeries without the device. The study aims to assess the safety and effectiveness of the TRBR Device in improving breast reconstruction outcomes. Data collected will be compared between the two groups to evaluate the potential benefits of the device.

Who should consider this trial

Good fit: Ideal candidates are women aged 22 and older who are undergoing their first breast reconstruction following a mastectomy due to breast cancer or for cancer prevention.

Not a fit: Patients who have had previous breast surgeries or complications, radiation therapy, or recent chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of breast reconstruction surgeries for patients post-mastectomy.

How similar studies have performed: While the use of tissue reinforcement in breast reconstruction is a novel approach, similar studies have shown promise in improving surgical outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Scottsdale, Arizona and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast Reconstruction Surgerybreast reconstructionpost-mastectomytissue expanderimplant based breast reconstructiontwo-stageimmediatesubpectoral
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.