Recruiting

Moni-Patch

Sponsor:

Murata Vios, Inc.

Code:

NCT07901296

Conditions

Body Temperature Monitoring

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Moni-Patch Temperature Monitoring Patch System

Study Details

Brief 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.

Conditions

Body Temperature Monitoring

Study ID

NCT07901296

Start date

Oct 3, 2026

Status verified date

Oct, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Moni-Patch Temperature Data Collection

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.

Interventions

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.

Primary outcome measure

  • Number of Participants With Evaluable Synchronized Moni-Patch and Esophageal Temperature Data [ Time Frame: During surgery, targeting at least 120 minutes of simultaneous temperature monitoring per participant. ]

Central Contacts and Locations

Central contacts

Locations

University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

Murata Vios, Inc.

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

  • Moni-Patch
  • Core Body Temperature
  • Esophageal Temperature
  • Algorithm Development
  • General Anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Murata Vios, Inc. on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.