NCT07397078

Clinical Accuracy Validation of the Moni-Patch Temperature Monitoring Patch System

Moni-Patch Temperature Monitoring Patch System Clinical Accuracy Validation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Murata Vios, Inc. · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Accepted

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.

Detailed 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 continuous 15-minute temperature monitoring session, during which both devices collect temperature values concurrently every 30 seconds. Environmental temperature and humidity are also recorded during the session.

Conditions

• Body Temperature
• Febrile

Interventions

Type	Name	Description
DEVICE	Moni-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.

Timeline

• Start date: 2026-01-21
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study