Lymphedema Sensor Technology Development Study

Northwestern University

Status: Completed

Conditions: Lymphedema Arm; Lymphedema; Cancer

Treatments: Device: Wearable devices to detect lymphedema

Study type: Observational

Funder types: Other

Identifiers

NCT06778837

STU00222670

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

All Participants

Treatment:

Device: Wearable devices to detect lymphedema