TRBR Device for Breast Reconstruction Surgery

Recruiting at 19 trial locations

Overseen By Mary Wexler

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Must not be taking: Systemic steroids

Disqualifiers: Radiation therapy, Chemotherapy, MRSA, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the TRBR Device for women undergoing their first breast reconstruction surgery after a mastectomy. The researchers aim to determine if the device can make the reconstruction process safer and more successful. Participants will join one of two groups: one group will receive the TRBR Device during surgery, while the other will undergo surgery without additional tissue support. Women who have had a mastectomy for breast cancer or to prevent cancer and are planning immediate implant-based reconstruction might be suitable for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future breast reconstruction outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking medications like systemic steroids that may increase the risk of complications, you might not be eligible to participate.

What prior data suggests that the TRBR Device is safe for breast reconstruction surgery?

Research shows that specific safety information for the TRBR Device used in breast reconstruction surgeries is not yet available. This device is investigational, meaning the FDA has not approved it for this purpose.

Devices used in breast reconstruction can generally present safety concerns, such as capsular contracture, where scar tissue forms tightly around a breast implant. However, without specific data, the tolerance of the TRBR Device remains unclear.

The study aims to gather information to better understand the safety and effectiveness of the TRBR Device. This process is a normal part of developing new treatments and helps ensure their safety for future use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TRBR Device is unique because it offers a new approach to two-stage implant-based breast reconstruction, potentially enhancing outcomes for patients. Unlike traditional methods that rely on existing implant techniques, the TRBR Device may provide improved tissue integration and stability. Researchers are excited because this device could lead to better aesthetic results and fewer complications, making the reconstruction process smoother and more effective for patients.

What evidence suggests that the TRBR Device is effective for breast reconstruction?

Research has shown that extra support in breast reconstruction surgery can lead to better results. This trial studies the TRBR Device as a method to improve the success of surgeries with implants. Similar methods have shown promise in stabilizing the area, potentially reducing complications and improving overall outcomes. Early results with these types of devices are promising, but more research is needed to fully understand the effectiveness of the TRBR Device. ^{1 3 6 7 8}

Who Is on the Research Team?

Dennis Hammond, MD

Principal Investigator

Partners in Plastic Surgery of West Michigan

Are You a Good Fit for This Trial?

This trial is for women aged 22 or older who are having their first breast reconstruction after a mastectomy, either due to breast cancer or as a preventive measure. Participants must be able to follow the study's procedures and attend all required follow-up visits.

Inclusion Criteria

I have signed the informed consent form.

I am a woman aged 22 or older.

I am scheduled for a mastectomy with immediate implant-based breast reconstruction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two-stage implant-based breast reconstruction with the TRBR Device

Varies

Multiple visits for surgical procedures and follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of major adverse events and physical well-being

1 year

What Are the Treatments Tested in This Trial?

Interventions

• TRBR Device

Trial Overview The TRBR Pivotal Clinical Study compares outcomes of patients using the new Tissue Reinforcement for Breast Reconstruction (TRBR) Device during surgery with those who had similar surgery without this device. The goal is to assess the safety and effectiveness of the TRBR Device in breast reconstruction.

How Is the Trial Designed?

Group I: Prospective Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

W.L.Gore & Associates

Lead Sponsor

Trials

103

Recruited

32,900+

Bret Snyder

W.L.Gore & Associates

Chief Executive Officer since 2020

MBA from Stanford University

Dr. John Doe

W.L.Gore & Associates

Chief Medical Officer since 2023

MD from Harvard Medical School

Avania

Industry Sponsor

Trials

59

Recruited

10,000+

Published Research Related to This Trial

A review of 714 adverse event reports related to mammography in women with breast implants revealed that 66 reports specifically noted issues during the procedure, with 62.1% of these cases involving breast implant ruptures.

Other reported complications included pain during mammography, difficulties in performing the procedure due to capsular contracture, and concerns about delayed cancer detection, highlighting the need for women with implants to be informed about these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast implant adverse events during mammography: reports to the Food and Drug Administration. Brown, SL., Todd, JF., Luu, HM.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06556654

Study Details | NCT06556654 | Tissue Reinforcement for ... 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, ...

2. withpower.com withpower.com/trial/phase-reconstruction-breast-surgery-8-2024-4c541

TRBR Device for Breast Reconstruction Surgery The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.

3. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15367.tissue-reinforcement-for-breast-reconstruction-trbr-pivotal-clinical-study-redefine.html

Tissue Reinforcement for Breast Reconstruction (TRBR) ... This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4236353/

Tissue Reinforcement in Implant-based Breast ... ADM-assisted direct-to-implant reconstruction is a safe and cost-effective alternative to 2-stage implant reconstruction, with low complication rates.

5. mayo.edu mayo.edu/research/clinical-trials/tests-procedures/breast-reconstruction-with-implants

Breast Reconstruction With Implants Clinical Trials The purpose of this study is to investigate the surgical outcomes that patients have after breast reconstruction, and to assess how reconstruction has affected ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-02975

Tissue Reinforcement for Breast Reconstruction (TRBR) ... This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. ... data/outcomes. Subject ...

7. mayo.edu mayo.edu/research/clinical-trials/tests-procedures/breast-reconstruction-with-flap-surgery

Breast Reconstruction With Flap Surgery Clinical Trials The purpose of this study is to demonstrate the safety and effectiveness of the Melodi Absorbable Antibacterial Matrix for soft tissue support in immediate, two ...

8. jcto.weill.cornell.edu jcto.weill.cornell.edu/open_clinical_trials/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-gore-redefine-study-tbr-22-07

Evaluation of the Safety and Effectiveness of the GORE® ... The study will look at the safety of the study device and the success of the participants' breast reconstruction. The TRBR Device is investigational, which ...