LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Edema
- Lymphedema
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective, randomized, control armMasking: Single (Outcomes Assessor)Masking Description: Partially Blinded: Patients will be informed which group they are randomized into and given the option to opt out of the study. Investigators (other than surgeons conducting surgery) and study personnel involved in patient measurements will be unaware of the patient treatment option.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04606030
- Collaborators
- University of Chicago
- Stanford University
- Investigators
- Principal Investigator: David W Chang, MD, FACS The University of Chicago Medicine & Biological Sciences Study Director: Dung H Nguyen, MD, PharmD Stanford University Study Director: Rebecca Garza, MD The University of Chicago Medicine & Biological Sciences
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