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

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

April 9, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2030

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

Trial Locations (20)

10065

RECRUITING

The Joan and Sanford I. Weill Medical College of Cornell University, New York

19104

RECRUITING

University of Pennsylvania, Philadelphia

19111

RECRUITING

The Fox Chase Cancer Center, Philadelphia

21205

RECRUITING

The Johns Hopkins University, Baltimore

32224

RECRUITING

Mayo Clinic Florida, Jacksonville

39216

RECRUITING

University of Mississippi, Jackson

44195

NOT_YET_RECRUITING

The Cleveland Clinic Foundation, Cleveland

49503

RECRUITING

Corewell Health Research Institute, Grand Rapids

53226

NOT_YET_RECRUITING

The Medical College of Wisconsin, Inc., Milwaukee

53715

RECRUITING

The Board of Regents of the University of Wisconsin System, Madison

60208

RECRUITING

Northwestern University, Evanston

67206

RECRUITING

BR Hope LLC, Wichita

85259

RECRUITING

Mayo Clinic Arizona, Scottsdale

85724

RECRUITING

University of Arizona, Tucson

90048

NOT_YET_RECRUITING

Cedars-Sinai Plastic and Reconstruction Surgery, Los Angeles

92555

RECRUITING

Riverside University Health System-Medical Center, Moreno Valley

98195

RECRUITING

The University of Washington Medical Center, Seattle

92697-7600

NOT_YET_RECRUITING

The Regents of the University of California, Irvine

60201-3137

RECRUITING

Endeavor Health (Northshore University HealthSystem Research Institute), Evanston

68198-5331

RECRUITING

The Board of Regents of the University of Nebraska, Omaha

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Avania

INDUSTRY

lead

W.L.Gore & Associates

INDUSTRY

NCT06556654 - Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE) | Biotech Hunter | Biotech Hunter