LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema
Fibralign Corporation
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.
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 l…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: The subject must be a breast cancer survivor, at least 3 years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention. Participants who are not able to safely undergo general anesthesia and/or perioperative care for VLNT are excluded. * Ages 18 to 75 years (inclusive) * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 * Life expectancy \> 2 years * Acquired (secondary) upper limb lymphedema secondary to breast cancer treatment * The participant must be eligible for surgical intervention * Swelling of 1 limb…
Interventions
- DeviceBioBridge® 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.
- ProcedureVascularized Lymph Node Transfer (VLNT)
Micro-surgical procedure for vascularized lymph node transfer (VLNT)
Locations (2)
- The University of Chicago Biological Sciences Division/University of Chicago Medical CenterChicago, Illinois
- MD AndersonHouston, Texas