Spots Global Cancer Trial Database for LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)

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Trial Identification

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

Official Title: LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema

Study ID: NCT04606030

Conditions

Lymphedema

Edema

Interventions

BioBridge® Collagen Matrix

Vascularized Lymph Node Transfer (VLNT)

Study Description

Brief 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 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. 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.