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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06556654

Enrollment

180

Registered

2024-08-16

Start date

2025-04-09

Completion date

2030-07-31

Last updated

2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction Surgery

Keywords

breast reconstruction, post-mastectomy, tissue expander, implant based breast reconstruction, two-stage, immediate, subpectoral, prepectoral

Brief 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.

Interventions

DEVICETRBR 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

This study is a investigational, multi-center, single-arm pivotal study to review safety outcomes of prospectively treated subjects who underwent two-stage implant-based breast reconstruction with the TRBR Device (TRBR Device group) to control subjects who underwent two-stage implant-based breast reconstruction with no mesh/ADM (Control group). Effectiveness of TRBR will be evaluated by comparing change from baseline (pre-index procedure) at 1-year post-index procedure in BREAST-Q.

Eligibility

Sex/Gender

FEMALE

Age

22 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Female subjects ≥ 22 years of age. 2. First-time breast reconstruction post-mastectomy for target breast(s). 3. Scheduled to undergo unilateral or bilateral mastectomy with immediate, two-stage, implant-based, subpectoral or prepectoral breast reconstruction after mastectomy. 4. Mastectomy performed to address breast cancer or for cancer prophylaxis. 5. An informed consent form is signed by Subject or Legally Authorized Representative (LAR). 6. Subject is capable of following protocol procedures and complying with follow-up visit requirements

Exclusion criteria

Baseline

Design outcomes

Primary

Measure	Time frame	Description
Absence of device- or procedure-related major adverse events (MAEs)	1 year post index procedure	Require rehospitalization or reoperation

Secondary

Measure	Time frame	Description
BREAST-Q Physical Well Being	1-year post-index procedure.	Chest Score change from baseline (pre-index procedure).

Countries

United States

Contacts

Primary ContactAriana O'Neill

TBR22-07@wlgore.com1 800-437-8181

Backup ContactMary Wexler