Recruiting

Testing a collagen scaffold with lymph node transplant surgery for arm swelling

Plain-English translation of NCT04606030 on ClinicalTrials.gov ↗ · Source last updated March 2025 · Translation generated July 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing whether a sterile collagen scaffold called BioBridge Collagen Matrix, placed during lymph node transplant surgery, can help reduce swelling in the arms of breast cancer survivors. The collagen scaffold is made from purified pork collagen and acts as a supportive framework during surgery. Researchers want to see if this treatment helps restore more normal arm volume and improves quality of life compared to transplant surgery alone.

Swelling in the arm after breast cancer treatment (lymphedema) can be difficult to manage with compression garments and physical therapy alone. Lymph node transplant surgery is a treatment option, but doctors want to know whether adding the collagen scaffold during surgery can make the results even better and help patients recover more arm function.

Do you qualify?

You likely qualify if…

you are a breast cancer survivor who finished cancer treatment at least 3 years ago and are disease-free
you have secondary lymphedema (swelling) in one arm that hasn't improved with elevation or compression
you are between 18 and 75 years old and able to safely undergo surgery and general anesthesia
you have completed at least 12 weeks of lymphedema therapy and have been wearing compression garments consistently
you have mild to moderate lymphedema (Stage I-II) based on medical staging
you have a life expectancy of more than 2 years and are otherwise in reasonably good health

You likely don't qualify if…

you have swelling caused by venous insufficiency (vein problems) rather than lymph system problems
you cannot safely undergo general anesthesia or major surgery
you recently started (within 12 weeks) lymphedema therapy
you have blood clots or other conditions that could cause sudden arm swelling
you are currently enrolled in another clinical trial testing a different treatment

What participation looks like

If you enroll, you will undergo vascularized lymph node transplant surgery—a procedure where healthy lymph nodes from another part of your body are surgically moved to your affected arm to restore lymphatic drainage. Half of participants will receive the surgery with the collagen scaffold added for support, while the other half will receive surgery alone. You will be followed for 12 months after surgery with measurements of your arm volume, quality of life surveys, and imaging tests to check how well your lymph system is working. You must commit to wearing compression garments as instructed throughout the study and following consistent self-care routines.

AI-generated summary from trial data · Jul 9, 2026 · Not medical advice

Trial locations(2 sites)

United States

The University of Chicago Biological Sciences Division/University of Chicago Medical Center, Chicago, Illinois

MD Anderson, Houston, Texas