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Clinical Accuracy Validation of the Moni-Patc Temperature Monitoring Patch During Surgery (Compared With Esophageal and Bladder Temperature)
Sponsor: Murata Vios, Inc.
Summary
Moni-Patc 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 esophageal and bladder temperature monitoring device used as the clinical reference.Main ObjectivesTo verify that the Moni-Patch and the reference device(esophageal and bladder) 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.
Official title: Moni-Patc Temperature Monitoring Patch System Clinical Accuracy Validation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2026-02-06
Completion Date
2026-06-30
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Moni-Patc Temperature Monitoring Patch System
A non-sterile, non-invasive temperature monitoring system applied to the neck; Bluetooth 5.0 transmission to a receiver; continuous core temperature estimation using dual heat-flux/thermistor-based algorithm; conforms to ISO 80601-2-56 (25-42 °C).