Lymphedema Sensor Technology Development Study

Northwestern University30 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Lymphedema Arm Lymphedema Cancer

Interventions

Wearable devices to detect lymphedemaDEVICE

All participants will undergo measurement of the upper extremities to test the validity and safety of wearable sensors to measure lymphedema.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: From enrollment to the end of the measurement session (appx. 3 hours)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Three hours

Data from ClinicalTrials.gov

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