Development and Clinical Validation of the LymphMonitor Technology to Quantitatively Assess Lymphatic Function.

Area of Science:

• Biomedical Engineering
• Vascular Biology
• Medical Diagnostics

Background:

• Current lymphatic vascular system diagnostics are often quantitative, costly, complex, and hospital-dependent.
• Limitations hinder effective assessment and monitoring of lymphatic function.

Purpose of the Study:

• To introduce LymphMonitor, a novel, quantitative, and simple outpatient technology for assessing lymphatic function.
• To evaluate the potential of LymphMonitor in diagnosing and monitoring lymphedema.

Main Methods:

• Painless injection of indocyanine green-human serum albumin tracer using microneedles.
• Monitoring fluorescence signal disappearance with a portable LymphMeter device over 3 hours.
• Calculating the area under the normalized clearance curve to quantify lymphatic function.

Main Results:

• LymphMonitor demonstrated a statistically significant difference in lymphatic clearance between healthy and lymphedema extremities.
• The area under the normalized clearance curve effectively quantified lymphatic function.

Conclusions:

• LymphMonitor technology shows promise as a quantitative tool for diagnosing and monitoring lymphatic function in patients.
• This method offers a simpler, outpatient alternative to existing diagnostic approaches for lymphatic disorders.