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Completed

NCT Number: NCT06778837

Lymphedema Sensor Technology Development Study

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.

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Key information

Conditions

Lymphedema Arm Cancer Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wearable devices to detect lymphedema

Device

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

Primary outcomes

  1. Tissue Hydration Score Recorded from the Tissue Hydration Sensor

    Time frame: 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). This is a continuous ratio level of measurement.

  2. Tissue Stiffness Score from the Tissue Stiffness Sensor

    Time frame: 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. This is a continuous ratio level of measurement.

Secondary outcomes

  1. Bioimpedance spectroscopy (BIS) L-Dex score

    Time frame: 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.

  2. Tissue Dielectric Constant (TDC)

    Time frame: 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.

  3. Volume of the Upper Extremities

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Robert H. Lurie Cancer Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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