🏛️ Verified NIH Record • Updated 2025-03-10

LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge) (NCT04606030)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Fibralign Corporation

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (22 items).

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

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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 (eg, 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
  • Current evidence, or a history of malignancy within the past 3 years (except for non melanoma skin cancer or cervical cancer in situ treated with curative intent). If the participant has undergone cancer treatment, this must have been completed \> 3 years prior to enrollment.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

  • The University of Chicago Biological Sciences Division/University of Chicago Medical Center — Chicago, Illinois
  • MD Anderson — Houston, Texas

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗