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BioBridge for Upper Extremity Lymphedema

This study is looking at a new way to improve surgery for lymphedema (swelling) in the arm. Researchers are investigating if adding a device called Fibralign BioBridge during standard surgery for vascularized lymph node transfer will lead to better results. The BioBridge is a thread-like scaffold designed to help new blood vessels form, which is important for the transplanted lymph nodes to work well. The goal is to see if this combination therapy can improve the outcome of surgical treatment for upper extremity lymphedema. You might be able to join if you are a woman between 18 and 75 years old with lymphedema in one arm that needs surgery and meets certain criteria for swelling severity. The study aims to enroll 60 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 60 women. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of improved surgical treatment will be measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05825157

Evaluation of Combination Therapy for Upper Extremity Lymphedema

Recruiting
NAAges 18–75InterventionalTreatment
Stanford University
~60 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:BioBridge

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improve the outcome of surgical treatment of upper extremity lymphedema
Measured over 12 months
+1 more outcome measured

Conditions

Lymphedema Arm

Explore related trials

Lymphedema

Where it's being run

1 sites across 1 states
California1

Who to contact

Dung Nguyen, MD, PharmD
[email protected]
(650) 725-2766
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Improve the outcome of surgical treatment of upper extremity lymphedema12 months

    To measure the post-surgical percent change in excess limb volume measured at 12 months following surgery using BioBridge scaffold as an adjunct to vascularized lymph node transfer for treatment of upper extremity lymphedema

  • Improve the outcome of surgical treatment of upper extremity lymphedema12 months

    Primary endpoint is % change in (excess) limb volume, from baseline to Month 12, in the intervention group relative to control group. Dispersion (variance) will be assessed as the standard deviation.