An interventional study of Moni-Patch Temperature Monitoring Patch System in Body Temperature and Febrile, sponsored by Murata Vios, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 7 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Murata Vios, Inc. · Not applicable, Interventional, and Diagnostic
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.
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.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's planned enrollment of 105 is below the median of 123 across 271 interventional studies indexed under Fever.
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Exclusion Criteria:
Subjects wear Moni-Patch on the neck and tympanic sensor in the ear for concurrent continuous temperature monitoring for 15 minutes after stabilization.
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.
Also known as: MP-P20U (Sensor), MP-D20U (Receiver)
Agreement between Moni-Patch™ Core Temperature Monitoring Patch System and Continuous Tympanic Temperature (Ttym) Measurements
Agreement will be quantified using the mean temperature difference (bias; °C) and Limits of Agreement (LOA; °C) between the Moni-Patch™ Temperature Monitoring Patch System and the comparative FDA-cleared continuous tympanic thermometer (Ttym). Paired temperature measurements (Moni-Patch vs. Ttym) collected every 30 seconds during continuous monitoring will be analyzed using Bland-Altman methodology. Name of Measurement: Core body temperature difference Measurement Tool(s): Moni-Patc Temperature Monitoring Patch System FDA-cleared continuous tympanic temperature monitoring device (Ttym) Unit of Measure: Degrees Celsius (°C) Analysis Method: Bland-Altman bias and 95% limits of agreement
Time frame: 15-minute continuous temperature monitoring period following a minimum 30-minute sensor acclimation period (per subject).
Plan to share: No — De-identified instrument data will be analyzed by the Sponsor; no public IPD sharing is planned.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Murata Vios, Inc.