Actively Recruiting
LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)
Led by Fibralign Corporation · Updated on 2025-03-11
60
Participants Needed
2
Research Sites
270 weeks
Total Duration
On this page
Sponsors
F
Fibralign Corporation
Lead Sponsor
U
University of Chicago
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
LymphBridge: Surgical Evaluation for Breast Cancer-Associated 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)
- ECOG Performance Status from 0 to 2
- Life expectancy greater than 2 years
- Secondary upper limb lymphedema due to breast cancer treatment
- Eligible for surgical intervention
- Swelling in one limb that does not fully improve with elevation or compression
- Stage I or II lymphedema based on International Society of Lymphology staging
- Completed full course of complete decongestive therapy with compression garments for at least 12 weeks prior to screening without changes
- Willing to consistently use compression garments during the study, except for the first 3 weeks after surgery
- Limb volume difference of at least 10% between affected and unaffected limbs
- Willing and able to comply with all study procedures including skin biopsy and imaging
- Able 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 VLNT
- Participation in any other investigational drug or therapy trial within 1 month before screening or 5 times the drug half-life
- Started complete decongestive physical therapy within 12 weeks before screening
- Medical conditions causing acute limb edema like venous thrombosis or heart failure
- Conditions causing symptoms like pain, swelling, or reduced motion overlapping with lymphedema
- History of clotting disorders
- Chronic infection in the affected limb
- Infection in the lymphedema limb within 1 month before screening
- Currently receiving chemotherapy or radiation therapy
- Evidence or history of malignancy within past 3 years except certain treated skin or cervical cancers
- Significant kidney or liver dysfunction based on laboratory tests
- Low neutrophil count or low hemoglobin 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 condition that investigator believes prevents full study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The University of Chicago Biological Sciences Division/University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
2
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Scully Hsu
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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