NCT02734979

Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To investigate whether 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 arm.

Detailed description

The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery.

Conditions

• Lymphedema
• Edema

Interventions

Type	Name	Description
DEVICE	Biobridge and lymph node transfer	Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery

Timeline

• Start date: 2016-07-20
• Primary completion: 2018-07-07
• Completion: 2020-10-29
• First posted: 2016-04-12
• Last updated: 2022-10-27
• Results posted: 2021-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study