Moni-Patch Temperature Data Collection for Algorithm Development During Surgery

NCT07901296 · tracked via the Priya Life Science USA tracker

Sponsor

Murata Vios, Inc

Phase

Not applicable

Started

2026-10-03

Last updated

2026-10-28

Condition(s) studied

Body Temperature Monitoring

Investigational drug(s) / intervention(s)

Moni-Patch Temperature Monitoring Patch System

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 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 informed consent 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 informed consent. 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.

Primary outcome measure(s)

Number of Participants With Evaluable Synchronized Moni-Patch and Esophageal Temperature Data — During surgery, targeting at least 120 minutes of simultaneous temperature monitoring per participant.
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.

Trial sites (1)

Facility	City	Region	Status
University of Minnesota Medical Center	Minneapolis	Minnesota	Recruiting

More Murata Vios, Inc. trials in the USA

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

Accuracy of Moni-Patch Compared With Tympanic Temperature Monitoring in Adults at Risk of Fever Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07901296 on ClinicalTrials.gov ↗ ← All trials in the USA