Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema
Stanford University
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.
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.
Eligibility
- Age range
- 18–75 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Ages 18 to 75 years (inclusive) * Life expectancy \> 2 years * Upper limb lymphedema * The participant must be eligible for surgical intervention * Swelling of 1 limb that is not completely reversed by elevation or compression * Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system * Participants with a history of cancer must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed. * Completion of a full course of complete decongestive ther…
Interventions
- DeviceBioBridge
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.
Location
- Stanford Hospital and ClinicsPalo Alto, California