TRBR Device for Breast Reconstruction Surgery

Recruiting at 1 trial location

Overseen By Ariana O'Neill

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

Trial Summary

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 data supports the effectiveness of the TRBR Device treatment for breast reconstruction surgery?

The research on the use of a titanium-coated polypropylene mesh (similar to the TRBR Device) in breast reconstruction shows that it has comparable patient satisfaction and safety outcomes to other methods, like using implants alone. This suggests that the TRBR Device might also be effective in providing satisfactory results in breast reconstruction. ^{1 2 3 4 5}

Is the TRBR Device safe for use in humans?

There is no specific safety data available for the TRBR Device, but general safety concerns for breast implants include risks like capsular contracture (tightening of scar tissue), implant rupture, and possible connective tissue disease. These risks are based on studies of silicone breast implants, which have been used in millions of women. ^{6 7 8 9 10}

How does the TRBR Device treatment for breast reconstruction differ from other treatments?

The TRBR Device for breast reconstruction is unique because it may involve a novel approach or material not specified in the available research, unlike traditional methods that use biological or synthetic meshes. Existing studies focus on different types of meshes, such as titanium-coated polypropylene or acellular dermal matrices, highlighting the ongoing search for optimal materials in implant-based breast reconstruction. ^{4 5 11 12 13}

What is the purpose of this trial?

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.

Research Team

Dennis Hammond, MD

Principal Investigator

Partners in Plastic Surgery of West Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes in Implant-Based Breast Reconstruction Alone or in Combination with a Titanium-Coated Polypropylene Mesh - A Detailed Analysis of the BREAST-Q and Overview of the Literature. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Reconstructive Trends After Tissue-Expander Loss in Breast Reconstruction. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Smooth Surface Tissue Expander Breast Reconstruction. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Implant Based Breast Reconstruction Using a Titanium-Coated Polypropylene Mesh (TiLOOP® Bra): A Systematic Review and Meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Comparing 200,000 Breast Implants and 85,000 Patients over Four National Breast Implant Registries. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Breast implant adverse events during mammography: reports to the Food and Drug Administration. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The safety of same-day breast reconstructive surgery: An analysis of short-term outcomes. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adverse event reporting in head and neck transoral robotic surgery: a MAUDE database study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The political and social context of silicone breast implant use in the United States. [2005]

11. United States pubmed.ncbi.nlm.nih.gov

Comparing the Outcomes and Complication Rates of Biologic vs Synthetic Meshes in Implant-Based Breast Reconstruction: A Systematic Review. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Novel devices for implant-based breast reconstruction: is the use of meshes to support the lower pole justified in terms of benefits? A review of the evidence. [2020]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Variation in the provision and practice of implant-based breast reconstruction in the UK: Results from the iBRA national practice questionnaire. [2021]