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.

Study Overview

• Status: Completed
• Conditions: Cancer; Lymphedema; Lymphedema Arm
• Intervention / Treatment: Device: Wearable devices to detect lymphedema

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will recruit patients using the above specified criteria in the Chicagoland area.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Participants	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue Hydration Score Recorded from the Tissue Hydration Sensor	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). This is a continuous ratio level of measurement.	From enrollment to the end of the measurement session (appx. 3 hours)
Tissue Stiffness Score from the Tissue Stiffness Sensor	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. This is a continuous ratio level of measurement.	From enrollment to the end of the measurement session (appx. 3 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioimpedance spectroscopy (BIS) L-Dex score	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.	Three hours
Tissue Dielectric Constant (TDC)	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.	From enrollment to the end of the measurement session (appx. 3 hours)
Volume of the Upper Extremities	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.	Three hours

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Robert H. Lurie Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Actual): December 3, 2025
• Study Completion (Actual): December 14, 2025

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Lymphedema; Cancer; Hydration; Device; Tissue; Upper Extremity; Stiffness; Sensor; Wearable
• Additional Relevant MeSH Terms: Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms; Lymphedema
• Other Study ID Numbers: STU00222670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No