Clinical Accuracy Validation of the Moni-Patch Temperature Monitoring Patch System
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7+
SponsorMurata Vios, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 7 years
Agree to Sensor placement on the neck and ear
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Moni-Patch Temperature Monitoring Patch System
DeviceWireless neck-applied Sensor paired with a Receiver via Bluetooth; heat flux and thermistor-based estimation of core temperature; sampling every 30 seconds.
Treatment groups
105 Participants
are divided into 1 treatment groupGroup A: Concurrent MonitoringExperimental treatment 1 intervention
Trial outcomes
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
Time frame
15-minute continuous temperature monitoring period following a minimum 30-minute sensor acclimation period (per subject).Sponsors and contacts
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Murata Vios, Inc.
Lead sponsor
Sonoma State University
Collaborator
Source ClinicalTrials.gov
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