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

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.

NCT Number	NCT07397078
Lead Sponsor	Murata Vios, Inc. Collaborators: Sonoma State University
Conditions	Body Temperature, Febrile
Enrollment	105 participants
Start Date	2026-01-21
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-09