Plain-English translation of NCT04606030 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · 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.
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.
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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
United States
Sponsor
Fibralign Corporation
Collaborators
University of Chicago
Enrollment target
~60 participants
Started
October 2020
Primary completion
October 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
18 Years – 75 Years
Last updated on clinicaltrials.gov in March 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Scully Hsu
The University of Chicago Medicine & Biological Sciences
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.