COMPLETED

Lymphedema Sensor Technology Development Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-27
Study Completion:2025-12-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06778837

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with a diagnosis of unilateral lymphedema that affects the upper extremity (UE).
  2. * Patients previously diagnosed with non-metastatic cancer.
  3. * Adults 18 years of age and older.
  1. * Patients with history of lymphatic surgery.
  2. * Patients with implantable devices (e.g., pacemaker, pacemaker/defibrillator, intrathecal pump, joint replacements, etc.) or any other device deemed unsafe by the treating investigator.
  3. * Patients with an amputation involving the upper extremity.
  4. * Patients with known allergies to adhesives - including silicone adhesives.
  5. * Patients with the following comorbidities: diabetes, congestive heart failure, peripheral vascular disease, irradiated upper extremity skin, psoriasis, atopic dermatitis, open wounds/skin breakdown.

Contacts and Locations

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-27
Study Completion Date2025-12-14

Study Record Updates

Study Start Date2025-01-27
Study Completion Date2025-12-14

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Lymphedema Arm
  • Lymphedema
  • Cancer