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RECRUITING
NCT05695924
NA

Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)

Sponsor: Fibralign Corporation

View on ClinicalTrials.gov

Summary

To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.

Official title: Prospective Evaluation of Nanofibrillar Collagen Scaffold (BioBridge®) as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-11-01

Completion Date

2025-12-01

Last Updated

2025-03-11

Healthy Volunteers

No

Conditions

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)

Locations (1)

Stanford University

Stanford, California, United States