TRBR Device for Breast Reconstruction Surgery
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
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo two-stage implant-based breast reconstruction with the TRBR Device
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of major adverse events and physical well-being
Treatment Details
Interventions
- TRBR Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
W.L.Gore & Associates
Lead Sponsor
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