NCT05825157

Evaluation of Combination Therapy for Upper Extremity Lymphedema

Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Investigate whether the addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. Will Biobridge improve upon the low success rate of the currently practiced surgery by facilitating the lymphatic connections to the transplanted node that are crucial to its viability and function.

Detailed description

Secondary lymphedema is the most common cause of lymphedema in the western world. Vascularized lymph node transfer (VLNT) is currently practiced with increasing frequency in the human disease population. This study will determined the efficacy of the Biobridge when used with VLNT in the human subjects with lymphedema; efficacy in large animal models has already been demonstrated. Patients with lymphedema who had BioBridge placed for soft tissue reinforcement after scar release has been observed to have improved lymph drainage and improvement of their limb volume.

Conditions

• Lymphedema Arm

Interventions

Type	Name	Description
DEVICE	BioBridge	Fibralign BioBridge is a thread-like, multi-lumen scaffold consisting of highly aligned collagen fibrils, optimized to encourage the endothelial cell attachment,alignment and migration that are prerequisites to new vessel formation. BioBridge is a device made from highly purified, medical-grade porcine collagen.

Timeline

• Start date: 2023-11-17
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2023-04-24
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study