60 Participants Needed

VLNT + BioBridge for Lymphedema

Recruiting at 2 trial locations
JG
SH
Overseen ByScully Hsu
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

RG

Rebecca Garza, MD

Principal Investigator

The University of Chicago Medicine & Biological Sciences

DW

David W Chang, MD, FACS

Principal Investigator

The University of Chicago Medicine & Biological Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex > 10 units.
I have swelling in my arm due to breast cancer treatment.
Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration.
See 12 more

Exclusion Criteria

You have used drugs or alcohol excessively in the past 6 months.
I am currently undergoing chemotherapy or radiation therapy.
My swollen limb was infected within the last month.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo vascularized lymph node transplant surgery (VLNT) with or without BioBridge Collagen Matrix implantation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in excess limb volume, quality of life, lymphatic function, and histological architecture

12 months
Regular visits (in-person) for assessments

What Are the Treatments Tested in This Trial?

Interventions

  • BioBridge® Collagen Matrix
  • Vascularized Lymph Node Transfer (VLNT)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: BioBridge treatment groupExperimental Treatment2 Interventions
Group II: Control groupActive Control1 Intervention

Vascularized Lymph Node Transfer (VLNT) is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Vascularized Lymph Node Transfer for:
🇪🇺
Approved in European Union as Vascularized Lymph Node Transfer for:
🇨🇦
Approved in Canada as Vascularized Lymph Node Transfer for:
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Approved in Japan as Vascularized Lymph Node Transfer for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fibralign Corporation

Lead Sponsor

Trials
2
Recruited
120+

Stanford University

Collaborator

Trials
2,527
Recruited
17,430,000+

University of Chicago

Collaborator

Trials
1,086
Recruited
844,000+
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