180 Participants Needed

TRBR Device for Breast Reconstruction Surgery

Recruiting at 1 trial location
JE
AO
Overseen ByAriana O'Neill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.45111213

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

DH

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.
See 3 more

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
1Treatment groups
Experimental Treatment
Group I: Prospective ArmExperimental Treatment1 Intervention
Prospectively treated subjects who undergo two-stage implant-based breast reconstruction with the TRBR Device (TRBR Device group)

Find a Clinic Near You

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

References

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]
Reconstructive Trends After Tissue-Expander Loss in Breast Reconstruction. [2023]
Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study. [2021]
Safety and Efficacy of Smooth Surface Tissue Expander Breast Reconstruction. [2023]
Implant Based Breast Reconstruction Using a Titanium-Coated Polypropylene Mesh (TiLOOPยฎ Bra): A Systematic Review and Meta-analysis. [2023]
Comparing 200,000 Breast Implants and 85,000 Patients over Four National Breast Implant Registries. [2023]
Breast implant adverse events during mammography: reports to the Food and Drug Administration. [2019]
The safety of same-day breast reconstructive surgery: An analysis of short-term outcomes. [2022]
Adverse event reporting in head and neck transoral robotic surgery: a MAUDE database study. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The political and social context of silicone breast implant use in the United States. [2005]
11.United Statespubmed.ncbi.nlm.nih.gov
Comparing the Outcomes and Complication Rates of Biologic vs Synthetic Meshes in Implant-Based Breast Reconstruction: A Systematic Review. [2023]
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]
Variation in the provision and practice of implant-based breast reconstruction in the UK: Results from the iBRA national practice questionnaire. [2021]
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