Lymphedema Sensor Technology Development Study

NCT ID: NCT06778837

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-27

Study Completion Date

2025-12-14

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphedema Arm Lymphedema Cancer

Keywords

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Sensor Device Lymphedema Upper Extremity Wearable Tissue Hydration Stiffness Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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All Participants

Wearable devices to detect lymphedema

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert H. Lurie Cancer Center

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Ann Marie Flores

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00222670

Identifier Type: -

Identifier Source: org_study_id