Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)

Part of paid clinical trials in Stanford, California.

Sponsor
Fibralign Corporation
Study ID
NCT05695924
Status
Recruiting
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Conditions

  • Edema
  • Lymphedema

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BioBridge® Collagen Matrix — DEVICE
    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.
  • Vascularized Lymph Node Transfer (VLNT) — PROCEDURE
    Micro-surgical procedure for vascularized lymph node transfer (VLNT)

Study Details

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.

Key Dates

Start date
Nov 1, 2023
Status verified
Mar 2025
Primary completion
Oct 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BioBridge treatment group
    Vascularized Lymph Node Transplant surgery (VLNT) supplemented by BioBridge Collagen Matrix implantation
  • Active Comparator: Control group
    Vascularized Lymph Node Transplant surgery (VLNT) only

Primary Outcome Measure

Excess limb volume change [ Time Frame: Baseline and 12 months after treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Dung H Nguyen, MD, PharmD

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By research site
Stanford University· Stanford, CA

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