Recruiting

Biobridge

Sponsor:

Stanford University

Code:

NCT05825157

Conditions

Lymphedema Arm

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BioBridge

Study Details

Brief summary:

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.

Conditions

Lymphedema Arm

Study ID

NCT05825157

Start date

Nov 17, 2023

Status verified date

Dec, 2025

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 18 to 75 years (inclusive)
  • Life expectancy > 2 years
  • Upper limb lymphedema
  • The participant must be eligible for surgical intervention
  • Swelling of 1 limb that is not completely reversed by elevation or compression
  • Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
  • Participants with a history of cancer must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed.
  • Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen
  • Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration.
  • Consistent use of an appropriately sized compression garment for daytime use.
  • Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other.
  • Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex > 10 units.
  • Willingness and ability to comply with all study procedures, including measurement of limb volume, skin biopsy, and preoperative and postoperative imaging studies.
  • Willingness and ability to understand, and to sign a written informed consent form document

Exclusion Criteria:

  • Edema arising from increased capillary filtration will be excluded (venous incompetence).
  • Inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer
  • Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half life, whichever is longer
  • Recent initiation (≤ 12 weeks) of CDPT for lymphedema
  • Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure
  • Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion)
  • History of clotting disorder (hypercoagulable state)
  • Chronic (persistent) infection in the affected limb
  • Infection of the lymphedema limb within 1 month prior to screening
  • Currently receiving chemotherapy or radiation therapy
  • Body Mass Index (BMI) >35
  • Known sensitivity to porcine products
  • Anaphylaxis to iodine
  • Pregnancy or nursing
  • Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
  • Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

BioBridge

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Dung Nguyen, MD, PharmD

(650) 725-2766nguyendh@stanford.edu

Elizabeth Tadevosyan, BS

818-269-1950etadyan@stanford.edu

Locations

Stanford Hospital and Clinics

Recruiting

Palo Alto, California, United States, 94304

Contacts

Dung Nguyen, MD PharmD

(650) 725-2766nguyendh@stanford.edu

Elizabeth Tadevosyan, BS

818-269-1950etadyan@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-12-24.