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Surgery

VLNT + BioBridge for Lymphedema

N/A
Recruiting
Led By David W Chang, MD, FACS
Research Sponsored by Fibralign Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18 to 75 years (inclusive)
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months after treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether adding a Fibralign BioBridge to standard surgery for vascularized lymph node transfer will improve outcomes for patients with lymphedema of the upper arm.

Who is the study for?
This trial is for breast cancer survivors aged 18-75, free of cancer for 3 years, with Stage I-II upper arm lymphedema after treatment. They must have completed decongestive therapy and be willing to wear compression garments consistently. Exclusions include clotting disorders, severe kidney or liver issues, recent infections in the affected limb, current chemotherapy/radiation, high BMI (>35), pregnancy/nursing, substance abuse history within 6 months.
What is being tested?
The LymphBridge study tests if adding BioBridge Collagen Matrix to standard vascularized lymph node transfer surgery improves outcomes for those with breast cancer-related upper arm lymphedema. Participants will undergo surgical intervention and follow-up care to assess the effectiveness of this combined treatment approach.
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection or reaction to anesthesia. Specific side effects related to BioBridge are not detailed but could involve local reactions at the implant site or complications from the lymph node transfer procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I can take care of myself and am up and about more than half of my waking hours.
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I have swelling in my arm due to breast cancer treatment.
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I am eligible for surgery.
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I have swelling in one limb that doesn't go away with rest or compression.
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My lymphedema is in the early or middle stage.
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I finished my breast cancer treatment 3 years ago and currently show no signs of the disease.
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I completed a full lymphedema treatment program 12 weeks ago, including wearing compression garments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My swelling is not due to poor vein function.
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I cannot safely have surgery under general anesthesia for lymph node transfer.
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I have not been in a drug study within the last month or 5 times the drug's half-life, whichever is longer.
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I have a condition that makes my blood clot more than normal.
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I have a long-lasting infection in my limb.
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I am currently undergoing chemotherapy or radiation therapy.
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My kidneys are not working well, with high creatinine or I need dialysis.
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My liver tests are higher than normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Excess limb volume change
Secondary study objectives
Histology
ICG fluorescence imaging
L-Dex bioimpedance spectroscopy.
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BioBridge treatment groupExperimental Treatment2 Interventions
Vascularized Lymph Node Transplant surgery (VLNT) supplemented by BioBridge Collagen Matrix implantation
Group II: Control groupActive Control1 Intervention
Vascularized Lymph Node Transplant surgery (VLNT) only

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER
2,468 Previous Clinical Trials
17,496,222 Total Patients Enrolled
13 Trials studying Lymphedema
6,512 Patients Enrolled for Lymphedema
University of ChicagoOTHER
1,053 Previous Clinical Trials
759,014 Total Patients Enrolled
Fibralign CorporationLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Lymphedema
60 Patients Enrolled for Lymphedema

Media Library

Vascularized Lymph Node Transfer (VLNT) (Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT04606030 — N/A
Lymphedema Research Study Groups: Control group, BioBridge treatment group
Lymphedema Clinical Trial 2023: Vascularized Lymph Node Transfer (VLNT) Highlights & Side Effects. Trial Name: NCT04606030 — N/A
Vascularized Lymph Node Transfer (VLNT) (Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04606030 — N/A
Lymphedema Patient Testimony for trial: Trial Name: NCT04606030 — N/A
~12 spots leftby Nov 2025
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