Lymphedema Sensor Technology Development Study

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

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.

Inclusion Criteria:

• Patients with a diagnosis of unilateral lymphedema that affects the upper extremity (UE).
• Patients previously diagnosed with non-metastatic cancer.
• Adults 18 years of age and older.

Exclusion Criteria:

• Patients with history of lymphatic surgery.
• Patients with implantable devices (e.g., pacemaker, pacemaker/defibrillator, intrathecal pump, joint replacements, etc.) or any other device deemed unsafe by the treating investigator.
• Patients with an amputation involving the upper extremity.
• Patients with known allergies to adhesives - including silicone adhesives.
• Patients with the following comorbidities: diabetes, congestive heart failure, peripheral vascular disease, irradiated upper extremity skin, psoriasis, atopic dermatitis, open wounds/skin breakdown.