Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

October 1, 2025

Study Completion Date

December 1, 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 (1)

94305

RECRUITING

Stanford University, Stanford

Sponsors
All Listed Sponsors
collaborator

Stanford University

OTHER

lead

Fibralign Corporation

INDUSTRY