Actively Recruiting
Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)
Led by Fibralign Corporation · Updated on 2025-03-11
60
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
F
Fibralign Corporation
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Breast cancer survivor at least 3 years after completing cancer therapy and free of clinical disease
- Age between 18 and 75 years inclusive
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- Life expectancy greater than 2 years
- Acquired upper limb lymphedema secondary to breast cancer treatment
- Eligible for surgical intervention
- Swelling of one limb not fully reversed by elevation or compression
- Stage I or II lymphedema at screening based on International Society of Lymphology (ISL) staging
- No evidence of disease (NED) and endocrine therapy allowed
- Completed complete decongestive therapy (CDT) with compression garments for at least 12 weeks before screening without changes
- Willingness to comply with self-care and consistent use of compression garments during the study (except first 3 weeks post-surgery)
- Consistent daytime use of an appropriately sized compression garment
- Limb volume difference of at least 10% between affected and unaffected limbs
- Evidence of abnormal bioimpedance ratio if feasible (L Dex > 10 units)
- Willingness and ability to comply with all study procedures including skin biopsy and imaging
- Ability to understand and sign informed consent
You will not qualify if you...
- Edema caused by increased capillary filtration such as venous incompetence
- Unable to safely undergo general anesthesia or perioperative care for vascularized lymph node transfer
- Participation in another investigational drug or therapy trial within 1 month or 5 times drug half-life
- Started complete decongestive physical therapy within 12 weeks prior to screening
- Medical conditions causing acute limb edema like venous thrombosis or heart failure
- Conditions causing symptoms overlapping lymphedema (pain, swelling, limited motion)
- History of clotting disorders (hypercoagulable state)
- Chronic infection in the affected limb
- Infection in the lymphedema limb within 1 month before screening
- Currently receiving chemotherapy or radiation therapy
- Active or recent malignancy within 3 years except treated non-melanoma skin or cervical cancer in situ
- Significant or chronic kidney failure or dialysis
- Liver dysfunction with elevated liver enzymes or bilirubin
- Low neutrophil count (<1500 mm3) at screening
- Low hemoglobin (<9 g/dL) at screening
- Body Mass Index over 35
- Known allergy to porcine products
- History of anaphylaxis to iodine
- Pregnancy or nursing
- Substance abuse within 6 months before screening
- Any other condition that prevents full participation as determined by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
Research Team
S
Shannon Meyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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