NCT05825157 · Stanford University
Evaluation of Combination Therapy for Upper Extremity Lymphedema
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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 measures
Improve the outcome of surgical treatment of upper extremity lymphedema
Time frame: 12 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 lymphedema
Time frame: 12 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Palo Alto, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations