Lymphedema Sensor Technology Development Study

NCT06778837 | Completed FDA Device

• 1 other identifier: STU00222670
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema Arm; Lymphedema; Cancer

Keywords

Sensor; Device; Lymphedema; Upper Extremity; Wearable; Tissue; Hydration; Stiffness; Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Bioimpedance spectroscopy (BIS) L-Dex score

  Three hours

• Tissue Dielectric Constant (TDC)

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

• Volume of the Upper Extremities

  Three hours

Study Arms (1)

All Participants

Device: Wearable devices to detect lymphedema

Interventions

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.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Robert H. Lurie Cancer Center: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Lymphedema; Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor at Northwestern University, Department of Physical Therapy and Human Movement Sciences, Director of Cancer Rehabilitation Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Director of Cancer Rehabilitation Stud

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 16, 2025
• Study Start: January 27, 2025
• Primary Completion: December 3, 2025
• Study Completion: December 14, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (1)