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
Qualifiers
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
Treatments tested in this trial
- Moni-Patch Temperature Monitoring Patch System
Treatment groups
105 Participants
are divided into 1 treatment groupSponsors and collaborators
Murata Vios, Inc.
Lead sponsor
Sonoma State University
Collaborator
Source ClinicalTrials.gov