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

NCT07397078 | Not Yet Recruiting FDA Device

• 1 other identifier: MPS2_01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Body Temperature; Febrile

Keywords

Core body temperature

Outcome Measures

Primary Outcomes (1)

• 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

  15-minute continuous temperature monitoring period following a minimum 30-minute sensor acclimation period (per subject).

Study Arms (1)

Concurrent Monitoring

EXPERIMENTAL

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

Interventions

Moni-Patch Temperature Monitoring Patch System DEVICE

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)

Concurrent Monitoring

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 7 years
• Agree to Sensor placement on the neck and ear

You may not qualify if:

• 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

Sponsors & Collaborators

• Murata Vios, Inc.: lead
• Sonoma State University: collaborator

Study Sites (1)

Murata Vios

Woodbury, Minnesota, 55125, United States

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ash Shibata

CONTACT

+1-612-497-7397; a.shibata@murata.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 9, 2026
• Study Start: January 21, 2026
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)