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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months after treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months after treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Excess limb volume change

Secondary outcome measures

Histology

ICG fluorescence imaging

L-Dex bioimpedance spectroscopy.

+1 more

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER

2,386 Previous Clinical Trials

17,333,948 Total Patients Enrolled

13 Trials studying Lymphedema

6,512 Patients Enrolled for Lymphedema

University of ChicagoOTHER

1,001 Previous Clinical Trials

817,670 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research protocol accommodate elderly participants?

"This trial is available to those between the ages of 18 and 75. Additionally, there are 9 trials designed for younger individuals and 161 studies centered around seniors."

Answered by AI

What is the total number of participants currently registered for this research?

"Affirmative. Clinicaltrials.gov has registered that this clinical trial, first released on October 26th of 2020, is currently searching for suitable volunteers with a goal of 60 participants from two distinct sites."

Answered by AI

Do I match the criteria to be recruited for this clinical study?

"This research is targeting 60 participants aged between 18 and 75 that suffer from limb edema. Eligibility criteria include being a breast cancer survivor for at least 3 years, having no current signs of illness, able to undergo general anaesthetic safely, life expectancy >2 years, Stage I-II lymphedema as judged by the International Society of Lymphology (ISL) staging system; completion of complete decongestive therapy according to ISL guidelines 12 weeks prior to screening with use of compression garments in the same time period."

Answered by AI

Is it possible to enroll in this experiment presently?

"Affirmative. Clinicaltrials.gov indicates that this research is currently recruiting participants, after being first posted on October 26th 2020 and last updated April 6th 2022. There are 60 openings for patients at two clinical sites."

Answered by AI

Who else is applying?

How old are they?

18 - 65

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

What state do they live in?

North Carolina

Louisiana

Texas

What site did they apply to?

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

MD Anderson

How many prior treatments have patients received?

Why did patients apply to this trial?

i ENCOURAGE RESEARCH & HOPE TO CONTRIBUTE AND BENEFIT. I’m active and I don’t want to be stuck with compression and the pump as my only options to manage this . I’d do the surgery out of pocket if I could, my insurance considers this experimental.

PatientReceived no prior treatments

I am frustrated with how little my health care providers can do to control my lymphedema. I wear a strong compression sleeve everyday, use my compression pump every other day and exercise in water. Yet, my arm continues to swell and ache. This motivated me to look into more drastic interventions.

PatientReceived 1 prior treatment