LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)
LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema
Fibralign Corporation
60 participants
Oct 26, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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.
Micro-surgical procedure for vascularized lymph node transfer (VLNT)
Locations(2)
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NCT04606030