Clinical Accuracy Validation of the Moni-Patch Temperature Monitoring Patch System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moni-Patch Temperature Monitoring Patch System.
- Who it may be relevant to
- Registry conditions: Body Temperature, Febrile. Basic parameters: from 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Moni-Patch Temperature Monitoring Patch System Clinical Accuracy Validation
Overview
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.
Detailed description
This study is conducted in accordance with ISO 80601-2-56:2017, which outlines definitions for temperature-measuring devices, age groups, required sample sizes, fever definitions, procedural flow, and statistical methods for clinical performance evaluation.
All subjects undergo temperature measurement using the reference device(Tympanic) and the investigational device (Moni-Patch Temperature Monitoring Patch System). The Moni-Patch Sensor is applied to the neck and paired with the Receiver, while the tympanic probe is positioned and sealed in the ear canal.
Each subject participates in a continuous 15-minute temperature monitoring session, during which both devices collect temperature values concurrently every 30 seconds.
Environmental temperature and humidity are also recorded during the session.
Interventions
- Device Moni-Patch Temperature Monitoring Patch System
Wireless neck-applied Sensor paired with a Receiver via Bluetooth; heat flux and thermistor-based estimation of core temperature; sampling every 30 seconds.
Primary outcome measures
- 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).]
Eligibility criteria
Inclusion criteria
- Age ≥ 7 years
- Agree to Sensor placement on the neck and ear
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Murata Vios — Woodbury
Identifiers
NCT: NCT07397078 · MPS2_01