NCT06778837

Lymphedema Sensor Technology Development Study

Validation of Wearable Sensors to Monitor Tissue Hydration and Stiffness in Patients With Lymphedema

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial in adult patients diagnosed with upper extremity lymphedema is to test the safety and effectiveness of small, wearable sensors that may be able to measure lymphedema. The main questions this study aims to answer are: * Do these sensors detect lymphedema? * If so, how accurate are these wearable sensors? Participants will complete one in-person measurement session and one phone call with study staff 14 days after the measurement session to check-in on the participant's well-being.

Conditions

• Lymphedema Arm
• Lymphedema
• Cancer

Interventions

Type	Name	Description
DEVICE	Wearable devices to detect lymphedema	All participants will undergo measurement of the upper extremities to test the validity and safety of wearable sensors to measure lymphedema.

Timeline

• Start date: 2025-01-27
• Primary completion: 2025-12-03
• Completion: 2025-12-14
• First posted: 2025-01-16
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study