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 (GORE REDEFINE Study, TBR 22-07)

Clinical Trial Details

This research study will look at breast reconstruction during mastectomy procedures. Data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device. The study will look at the safety of the study device and the success of the participants' breast reconstruction.

The TRBR Device is investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA) for this treatment.

After the index procedure and exchange procedure, participants will be asked to do daily entries regarding their health for 30 days. All study visits will be part of the standard of care.

Total study participation is approximately 3 years, with the ability to opt into an additional 7-year follow-up (10 years total).

Key Eligibility:

Open to female patients 22 years and older scheduled to undergo first-time breast reconstruction post-mastectomy for cancer prophylaxis
Participants must not be undergoing chemotherapy within 3 weeks of the procedure or have undergone radiation therapy to the reconstruction site.

Detailed eligibility will be reviewed when contacting the study team.

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Protocol ID(s)

Weill Cornell Medicine IRB #:

2409027920

ClinicalTrials.gov:

NCT06556654

Status

Not Yet Recruiting

Age Group

Adult

Disease

Breast Cancer

Surgery