Moni-Patch Temperature Monitoring Patch System Clinical Accuracy Validation
Murata Vios, Inc.
Summary
Moni-Patch Temperature Monitoring Patch System, a non-invasive, continuous temperature monitoring device designed to estimate core body temperature by applying a Sensor to the neck. This clinical accuracy validation study aims to verify the accuracy and repeatability of the Moni-Patch compared with an FDA-cleared continuous tympanic temperature monitoring device used as the clinical reference. Main objectives of this study are; To verify that the Moni-Patch and the reference device(tympanic) demonstrate acceptable agreement, as defined by Bland-Altman Analyses (bias within ±0.4°C and limits of agreement between -1.0°C and 1.0°C). To verify the consistency and repeatability of temperature measurements obtained from the Moni-Patch during continuous monitoring.
Description
This study is conducted in accordance with ISO 80601-2-56:2017, which outlines definitions for temperature-measuring devices, age groups, required sample sizes, fever definitions, procedural flow, and statistical methods for clinical performance evaluation. All subjects undergo temperature measurement using the reference device(Tympanic) and the investigational device (Moni-Patch Temperature Monitoring Patch System). The Moni-Patch Sensor is applied to the neck and paired with the Receiver, while the tympanic probe is positioned and sealed in the ear canal. Each subject participates in a con…
Eligibility
- Age range
- 7+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age ≥ 7 years * Agree to Sensor placement on the neck and ear Exclusion Criteria: * Ear conditions contraindicating tympanic probe; skin issues at placement sites * Antipyretic use within 120 minutes; inability to position neck Sensor over carotid * Inability to seal tympanic sensor; tympanic membrane not visually confirmed
Interventions
- DeviceMoni-Patch Temperature Monitoring Patch System
Wireless neck-applied Sensor paired with a Receiver via Bluetooth; heat flux and thermistor-based estimation of core temperature; sampling every 30 seconds.
Location
- Murata ViosWoodbury, Minnesota