VLNT + BioBridge for Lymphedema

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byDavid W Chang, MD, FACS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Fibralign Corporation

No Placebo Group

Approved in 4 Jurisdictions

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.

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.

+13 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.

+18 more

Trial 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

Participant Groups

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.

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

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: