Lymphedema Sensor Technology Development Study

Recruiting

• Conditions: Lymphedema Arm; Lymphedema; Cancer

• Registration Number: NCT06778837
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-16
• Last Update Posted: 2025-01-16
• Study Start: 2025-01-20
• Primary Completion: 2026-06-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tissue Hydration Score Recorded from the Tissue Hydration Sensor	From enrollment to the end of the measurement session (appx. 3 hours)	This score will determine whether or not fluid associated with lymphedema is detected when compared to previously validated measures (bioimpedance spectroscopy and tissue dielectric constant).
Tissue Stiffness Score from the Tissue Stiffness Sensor	From enrollment to the end of the measurement session (appx. 3 hours)	This score will determine whether or not tissue affected by lymphedema can yield is detected when compared to a comparable clinical measurement device using Young's Modulus.

Secondary Outcome Measures

Name	Time	Method
Bioimpedance spectroscopy (BIS) L-Dex score	Three hours	The bioimpedance spectroscopy L-Dex score is a ratio that represents the difference in the amount of extracellular fluid in an at-risk limb compared to an unaffected limb.
Tissue Dielectric Constant (TDC)	From enrollment to the end of the measurement session (appx. 3 hours)	The tissue dielectric constant (TDC) is derived from an electromagnetic wave that is reflected back from transmission into the tissue. It represents free and bound water in the tissue.
Volume of the Upper Extremities	Three hours	Circumferential volumetric measurement is obtained by modeling the limb as a frustum and taking a series of circumferential measurements using anatomical landmarks at predetermined intervals (typically every 4cm), beginning at the wrist and ending at the anterior axillary fold. Volume differences of +10% represents the presence of lymphedema.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States