Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID04606030

LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema

Led by Fibralign Corporation · Updated on 2025-03-11

60

Participants Needed

2

Research Sites

8 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

Researchers are evaluating whether adding Fibralign's BioBridge Collagen Matrix devices to standard vascularized lymph node transfer surgery (VLNT) can improve treatment outcomes for upper arm lymphedema caused by breast cancer. This study focuses on patients who have developed secondary lymphedema after breast cancer therapy and aims to measure changes in limb swelling and lymphatic function. The BioBridge is a sterile, implantable surgical mesh made from purified porcine collagen designed to support soft tissue during VLNT. Participants will be randomly assigned to one of two groups: one receiving VLNT surgery with the BioBridge implant and the other receiving VLNT surgery alone. The BioBridge device supports the lymphatic tissues during surgery. Both groups will undergo the surgical procedure followed by a 12-month follow-up period. The study includes monitoring using imaging and quality of life assessments to evaluate the treatment effects. Throughout the study, participants will have measurements of their limb volume taken at the start and 12 months after surgery to assess changes in swelling. Additional evaluations include quality of life surveys (LLIS), bioimpedance spectroscopy (L-Dex), lymphatic function imaging with indocyanine green fluorescence, and tissue histology. Participants are expected to consistently use compression garments and adhere to self-care recommendations. Safety and treatment outcomes will be monitored throughout the study duration, which lasts at least 12 months post-treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 18 to 75 years inclusive
  • Breast cancer survivors at least 3 years beyond completion of cancer therapy with no clinical disease
  • Eligible for vascularized lymph node transfer surgery
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
  • Life expectancy greater than 2 years
  • Acquired upper limb lymphedema secondary to breast cancer treatment
  • Swelling in one limb not fully reversible by elevation or compression
  • Stage I-II lymphedema based on International Society of Lymphology staging
  • Completed full course of complete decongestive therapy (CDT) including compression garments for at least 12 weeks before screening with no changes
  • Willingness to consistently use compression garments and comply with self-care during the study, except for the first 3 weeks post-surgery
  • Limb volume difference of at least 10% between affected and unaffected limbs
  • Evidence of abnormal bioimpedance ratio (L Dex > 10) if feasible
  • Ability and willingness to comply with all study procedures and sign informed consent
Not Eligible

You will not qualify if you...

  • Edema caused by increased capillary filtration (venous incompetence)
  • Unable to safely undergo general anesthesia or perioperative care for surgery
  • Participation in another investigational drug or therapy trial within 1 month before screening or 5 times the drug's half-life
  • Recent start (within 12 weeks) of complete decongestive physical therapy (CDPT) for lymphedema
  • Medical conditions causing acute limb edema such as venous thrombosis or heart failure
  • Conditions causing symptoms overlapping lymphedema such as pain, swelling, or limited motion
  • History of clotting disorders
  • Chronic infection in the affected limb
  • Infection of the lymphedema limb within 1 month prior to screening
  • Currently receiving chemotherapy or radiation therapy
  • Current or recent (within 3 years) malignancy except certain treated skin or cervical cancers
  • Significant or chronic kidney failure or dialysis
  • Liver dysfunction with elevated enzymes or bilirubin
  • Low neutrophil count or hemoglobin levels
  • Body mass index over 35
  • Known allergy to porcine products
  • Anaphylaxis to iodine
  • Pregnancy or nursing
  • Substance abuse within 6 months prior to screening
  • Any other condition that prevents full participation as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 3 weeks post-surgery

Participants undergo vascularized lymph node transplant surgery (VLNT) with or without BioBridge Collagen Matrix implantation, followed by immediate post-operative care.

1 surgery visit and weekly follow-up visits during the first 3 weeks

Post-operative Follow-up

Duration - 12 months

Participants are monitored for changes in limb volume, quality of life, lymphatic function, and other measures for up to 12 months after surgery.

Visits at baseline and 12 months after treatment

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

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Research Team

S

Scully Hsu

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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Published Research Related To This Trial

The role of adjunct nanofibrillar collagen scaffold implantation in the surgical management of secondary lymphedema: Review of the literature and summary of initial pilot studies.

Danielle H Rochlin, Suzanne Inchauste, Justin Zelones...

https://pubmed.ncbi.nlm.nih.gov/31209884