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Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema

Lymphedema Arm Clinical Trial

Official title:
Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05825157
Study type Interventional
Source Stanford University
Contact
Status Not yet recruiting
Phase N/A
Start date June 1, 2023
Completion date January 1, 2028
View Details
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