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Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

NCT06556654 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-10-23

No results posted yet for this study

Summary

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.

Conditions

  • Breast Reconstruction Surgery

Interventions

DEVICE

TRBR Device

The GORE® Tissue Reinforcement for Breast Reconstruction device is intended to reinforce the soft tissue surrounding the tissue expander in preparation for the breast implant in post-mastectomy breast reconstruction

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Dennis Hammond, MD · Partners in Plastic Surgery of West Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-09
Primary Completion
2027-07-31
Completion
2030-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06556654 on ClinicalTrials.gov