Development of wearable sensors for measuring lymphedema
Validation of Wearable Sensors to Monitor Tissue Hydration and Stiffness in Patients with Lymphedema
This study is testing new wearable sensors to see if they can accurately measure lymphedema in adults who have had non-metastatic cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06778837 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of small, wearable sensors designed to detect lymphedema in adults with upper extremity lymphedema, particularly those with a history of non-metastatic cancer. Participants will undergo an in-person measurement session followed by a follow-up phone call 14 days later to assess their well-being. The study seeks to determine whether these sensors can accurately measure lymphedema and how reliable they are in clinical settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unilateral upper extremity lymphedema and a history of non-metastatic cancer.
Not a fit: Patients with a history of lymphatic surgery, implantable devices, or certain comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could provide a non-invasive and accurate method for monitoring lymphedema, improving patient management and outcomes.
How similar studies have performed: While wearable sensor technology is emerging, this specific approach to measuring lymphedema is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Bridget C Groble, B.S.
- Email: bridget.groble@northwestern.edu
- Phone: 312-503-5067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.