NCT05695924

Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fibralign Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study utilizes Fibralign's BioBridge® Collagen Matrix (BioBridge), a sterile implantable biocompatible 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 study will investigate whether addition of the BioBridge Collagen Matrix to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. This clinical study will also be used in support of IDE G200200 review conducted by the FDA. Primary endpoint is the post surgical % change in excess limb volume, measured at 12 months following the surgical procedure. Secondary endpoints are change in quality of life scores measured by LLIS and change in lymphatic function as measured by indocyanine green (ICG) fluorescence imaging.

Conditions

• Lymphedema
• Edema

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2023-01-25
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study