This study evaluates the feasibility of using wearable and wireless sensor technology in patients with lymphedema, including measuring skin hydration, lymphedema and optimal placement of wearable and wireless sensors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06778837.
PRIMARY OBJECTIVES:
I. To evaluate the safety and efficacy of a new wearable sensor device capable of measuring tissue hydration for clinical presentation of lymphedema.
II. To evaluate the safety and efficacy of tissue stiffness for clinical presentation of lymphedema.
OUTLINE: This is an observational study.
Patients undergo skin assessment, bioimpedance spectroscopy measurement, limb circumference measurements, tissue hydration and stiffness measurements, photography and complete questionnaires.
Trial PhaseNo phase specified
Trial Typedevice
Lead OrganizationNorthwestern University
Principal InvestigatorAnn Marie Flores