VLNT + BioBridge for Lymphedema

Recruiting at 2 trial locations

Overseen By Scully Hsu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fibralign Corporation

Must not be taking: Chemotherapy, Radiation therapy

Disqualifiers: Heart failure, Clotting disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

60 Participants Needed

Trial Summary

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.

Research Team

Rebecca Garza, MD

Principal Investigator

The University of Chicago Medicine & Biological Sciences

David W Chang, MD, FACS

Principal Investigator

The University of Chicago Medicine & Biological Sciences

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: BioBridge treatment group Experimental Treatment 2 Interventions

Vascularized Lymph Node Transplant surgery (VLNT) supplemented by BioBridge Collagen Matrix implantation

Group II: Control group Active Control 1 Intervention

Vascularized Lymph Node Transplant surgery (VLNT) only

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:

• Upper extremity lymphedema
• Lower extremity lymphedema

Approved in European Union as Vascularized Lymph Node Transfer for:

• Upper extremity lymphedema
• Lower extremity lymphedema
• Breast cancer-related lymphedema

Approved in Canada as Vascularized Lymph Node Transfer for:

• Upper extremity lymphedema
• Lower extremity lymphedema

Approved in Japan as Vascularized Lymph Node Transfer for:

• Upper extremity lymphedema
• Lower extremity lymphedema

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+