Clinical trial · Observational
Lymphedema Sensor Technology Development Study
Validation of Wearable Sensors to Monitor Tissue Hydration and Stiffness in Patients With Lymphedema
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lymphedema | — | UNRESOLVED | — |
| Lymphedema Arm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Wearable devices to detect lymphedema | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All Participants
- interventionNames
- Device: Wearable devices to detect lymphedema
Primary outcomes (2)
- measure
- Tissue Hydration Score Recorded from the Tissue Hydration Sensor
- timeFrame
- From enrollment to the end of the measurement session (appx. 3 hours)
- description
- 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.
- measure
- Tissue Stiffness Score from the Tissue Stiffness Sensor
- timeFrame
- From enrollment to the end of the measurement session (appx. 3 hours)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available