An interventional study of Moni-Patch Temperature Monitoring Patch System in Body Temperature Monitoring, sponsored by Murata Vios, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Murata Vios, Inc. · Not applicable, Interventional, and Other
This study aims to collect synchronized temperature measurements from the Moni-Patch Temperature Monitoring Patch System and an esophageal temperature probe during surgery to support the development and refinement of the Moni-Patch temperature estimation algorithm.
Approximately 30 adult patients undergoing elective surgery under general anesthesia will participate. Moni-Patch will be applied non-invasively to the neck, while esophageal temperature will be monitored as part of routine clinical care.
Temperature data and related perioperative information will be collected for algorithm development and internal feasibility evaluation.
This study is not designed to validate clinical accuracy or assess whether predefined accuracy criteria are met.
This is a prospective, single-center study designed to collect synchronized Moni-Patch and esophageal temperature data for algorithm development and refinement.
Approximately 30 adult patients undergoing elective surgery under general anesthesia lasting at least 120 minutes will be enrolled.
A Moni-Patch sensor will be attached to the skin over the carotid artery in the neck. The sensor will communicate wirelessly with a PC-based data logger to continuously record temperature measurements and device data.
Esophageal temperature will be monitored using a clinically indicated temperature probe connected to the patient monitoring system.
Synchronized temperature data will be collected during surgery. At least 120 minutes of valid simultaneous Moni-Patch and esophageal temperature measurements will be targeted for each participant.
Data collection will also include patient characteristics, surgical and anesthesia information, warming conditions, device-use information, and relevant environmental conditions.
The collected data will be used to identify opportunities for algorithm improvement and to characterize device performance internally. Descriptive analyses may be performed, but no formal clinical accuracy hypothesis test or pass/fail acceptance criterion is planned.
Moni-Patch readings will not be used to guide clinical care.
Murata Vios, Inc. is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Adults aged 18 years or older.
Patients scheduled for elective surgery under general anesthesia expected to last at least 120 minutes.
Patients for whom continuous esophageal temperature monitoring is planned as part of routine clinical care.
Patients able to provide their own written and who agree to Moni-Patch sensor placement on the neck before surgery.
Patients in whom the Moni-Patch sensor can be securely attached over the carotid artery without interfering with the surgical field or wireless connection to the data logger.
Patients undergoing procedures in an environment meeting the device operating requirements of 15-40°C and 30-75% relative humidity.
For non-English-speaking patients, a translator must be available during the informed consent process.
Exclusion Criteria:
Patients unable to provide their own .
Patients with esophageal conditions contraindicating placement of an esophageal temperature probe.
Patients whose planned procedures do not include esophageal temperature monitoring.
Patients undergoing procedures that prevent placement of the required esophageal temperature probe.
Patients with skin inflammation, scratches, redness, rash, or other conditions at the Moni-Patch placement site.
Patients in whom the Moni-Patch sensor cannot be securely attached or accurately positioned over the carotid artery.
Patients undergoing procedures involving MRI or CT environments where device use is prohibited by the protocol.
Patients for whom device operating environment requirements cannot be met.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo continuous temperature monitoring using the Moni-Patch system during elective surgery. Moni-Patch data will be collected simultaneously with clinically indicated esophageal temperature measurements for algorithm development and refinement.
Device: Moni-Patch Temperature Monitoring Patch System
A non-invasive, wireless temperature monitoring system consisting of a sensor attached to the skin over the carotid artery in the neck and a PC-based data logger. The system collects continuous temperature and device data for development of the temperature estimation algorithm. The investigational device will not be used for clinical decision-making.
Number of Participants With Evaluable Synchronized Moni-Patch and Esophageal Temperature Data
The number of participants with at least 120 minutes of valid simultaneous Moni-Patch and esophageal temperature measurements collected during surgery. Data will be used for algorithm development, refinement, and descriptive evaluation. No formal clinical accuracy hypothesis testing or pass/fail acceptance criteria will be applied. Time Frame: During surgery, targeting at least 120 minutes of simultaneous temperature monitoring per participant. Important: This is a proposed operational data-collection outcome for ClinicalTrials.gov registration. The protocol does not formally designate a primary clinical outcome. The wording should be confirmed with the Sponsor and study team before submission.
Time frame: During surgery, targeting at least 120 minutes of simultaneous temperature monitoring per participant.
Plan to share: No — Individual participant-level data are intended for internal algorithm development and refinement. No public IPD-sharing plan is specified in the protocol.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Apr 2027, 5 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Murata Vios, Inc.