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

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.

Eligibility

Age range

22+ years

Sex

Female

Healthy volunteers

No

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

Locations (20)