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

Starting soon · Not applicable

Conditions studied: Body Temperature, Febrile

In brief

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.

Key facts

Study ID

NCT07397078

Run by

Murata Vios, Inc.

People needed

105

Starts

2026-01-21

Expected to finish

2026-03-31

Last updated by the study team

2026-02-09

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Murata Vios — Woodbury, Minnesota, United States

Full record on ClinicalTrials.gov

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