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

Part of paid clinical trials in Woodbury, Minnesota.

Sponsor
Murata Vios, Inc.
Study ID
NCT07397078
Status
Not Yet Recruiting

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Conditions

  • Body Temperature
  • Febrile

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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 Dates

Start date
Jan 21, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
105 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Concurrent Monitoring
    Subjects wear Moni-Patch on the neck and tympanic sensor in the ear for concurrent continuous temperature monitoring for 15 minutes after stabilization.

Primary Outcome Measure

Agreement between Moni-Patch™ Core Temperature Monitoring Patch System and Continuous Tympanic Temperature (Ttym) Measurements [ Time Frame: 15-minute continuous temperature monitoring period following a minimum 30-minute sensor acclimation period (per subject). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Murata ViosWoodburyMinnesota55125-

Find similar trials in Woodbury, MN

By research site
Murata Vios· Woodbury, MN

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