Evaluation of Combination Therapy for Upper Extremity Lymphedema

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT05825157
Status
Recruiting
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Conditions

  • Lymphedema Arm

Eligibility Criteria

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

Interventions

  • BioBridge — DEVICE
    Fibralign BioBridge is a thread-like, multi-lumen scaffold consisting of highly aligned collagen fibrils, optimized to encourage the endothelial cell attachment,alignment and migration that are prerequisites to new vessel formation. BioBridge is a device made from highly purified, medical-grade porcine collagen.

Study Details

Investigate whether the addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. Will Biobridge improve upon the low success rate of the currently practiced surgery by facilitating the lymphatic connections to the transplanted node that are crucial to its viability and function.

Key Dates

Start date
Nov 17, 2023
Status verified
Dec 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2029

Study Design

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

Arms

  • Active Comparator: VLNT
    Standard of care vascularized lymph node transfer
  • Experimental: VLNT with Biobridge
    Standard of care vascularized lymph node transfer plus BioBridge placement

Primary Outcome Measure

Improve the outcome of surgical treatment of upper extremity lymphedema [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Hospital and ClinicsPalo AltoCalifornia94304
Dung Nguyen, MD PharmD
[email protected]
(650) 725-2766
Elizabeth Tadevosyan, BS
[email protected]
818-269-1950

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By research site
Stanford Hospital and Clinics· Palo Alto, CA

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