LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 26, 2020

Primary Completion Date

October 30, 2025

Study Completion Date

December 30, 2025

Conditions
LymphedemaEdema
Interventions
DEVICE

BioBridge® Collagen Matrix

BioBridge Collagen Matrix (BioBridge) is a sterile implantable bio-compatible and biodegradable surgical mesh ribbon comprised of highly purified porcine collagen. The Class II device was cleared by CDRH Division of Surgical Devices on 8 January 2016 under 510(k) K151083. The device will be used for soft tissue surgical support at the time of vascularized lymph node transplant surgery (VLNT); the device will be used, specifically, for surgical support of the lymphatic component of the soft tissue.

PROCEDURE

Vascularized Lymph Node Transfer (VLNT)

Micro-surgical procedure for vascularized lymph node transfer (VLNT)

Trial Locations (2)

60637

RECRUITING

The University of Chicago Biological Sciences Division/University of Chicago Medical Center, Chicago

77030

RECRUITING

MD Anderson, Houston

Sponsors
All Listed Sponsors
collaborator

University of Chicago

OTHER

lead

Fibralign Corporation

INDUSTRY

NCT04606030 - LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge) | Biotech Hunter | Biotech Hunter