Clinical Accuracy Validation of the Moni-Patc Temperature Monitoring Patch During Surgery (Compared With Esophageal and Bladder Temperature) (Moni-Patch OR)

Moni-Patc Temperature Monitoring Patch System Clinical Accuracy Validation

Moni-Patc 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 esophageal and bladder temperature monitoring device used as the clinical reference.Main ObjectivesTo verify that the Moni-Patch and the reference device(esophageal and bladder) 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Temperature Monitoring; Intraoperative
• Intervention / Treatment: Device: Moni-Patc Temperature Monitoring Patch System

Detailed Description

This single-center, open-label accuracy validation compares continuous core temperature measured by the Moni-Patch applied on the neck with esophageal (T_eso) and bladder (T_bld) temperatures during elective surgeries under general anesthesia. Approximately 30 adult participants will be monitored for ≥60 minutes intraoperatively. Agreement will be assessed using Bland-Altman methods (bias and 95% limits of agreement). The device is non-invasive and Bluetooth-enabled; readings are captured via the receiver and routed to the OR multi-parameter monitor and EMR. Safety monitoring focuses on device-related skin reactions and device deficiencies; no changes to anesthetic care are mandated by the protocol.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Ash Shibata Senior Manager; Phone Number: 612-497-7397; Email: a.shibata@murata.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population consists of adult patients aged 18 years and older who are undergoing elective surgical procedures under general anesthesia in the operating room. Eligible participants are those for whom continuous esophageal and bladder temperature monitoring is clinically indicated as part of routine perioperative care and who are expected to remain hospitalized overnight following surgery.

Participants will have the Moni-Patch Temperature Monitoring Patch System applied to the neck for continuous, non-invasive temperature monitoring during surgery. The study population will include a range of body mass index (BMI) categories to support evaluation of device performance across different body habitus. Subjects must be able to provide informed consent and meet environmental and clinical conditions required for use of the study device.

Description

Inclusion Criteria:

1. Age ≥18 years
2. Subject is undergoing an elective surgical procedure expected to require at least 60min of general anesthesia and during which routine esophageal (Teso) and bladder (Tbld) temperature monitoring is expected.
3. Subjects are expected to remain hospitalized at least overnight after surgery.
4. Subject specifically agrees to temperature Sensor placement on the neck prior to surgery.
5. Must be able to attach the Sensor away from the operative field (neck) with uninterrupted wireless connection between the Sensor and the Receiver (as close as possible).

6. Use environment must meet both of the following parameters:

   1. Temperature 15-40⁰ C/59-104⁰ F
   2. Humidity 30-75% RH (non-condensing)
7. For non-English speaking subjects, a translator must be present at the time of consent.

Exclusion Criteria:

1. Subjects unable to provide their own consent. Consent from family or LOR is not acceptable.
2. Subjects undergoing surgical procedures who have conditions of the esophagus or bladder that contraindicate placement of these monitoring probes/sensor.
3. Subjects whose surgery does not involve the monitoring of esophageal or bladder temperature.
4. Subjects undergoing surgery that prohibits placement of an esophageal temperature monitoring probe/sensor (e.g. neck surgery).
5. Subjects with medical conditions such as inflammation, scratches, redness, rash at the Sensor placement site.
6. Subjects for whom the sensor cannot be securely adhered to the skin without floating or detaching, or accurately positioned over the carotid artery.
7. Not for use in MRI or CT facilities.
8. Use environment does not meet one or more parameters.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement Between Moni-Patch™ Temperature Monitoring Patch System and Esophageal (Teso) and Bladder (Tbld) Core Temperature Measurements	This outcome assesses agreement between the Moni-Patch™ Temperature Monitoring Patch System and clinical reference core temperature measurements obtained using FDA-cleared esophageal temperature probes (Teso) and FDA-cleared bladder temperature probes (Tbld) during general anesthesia. Paired temperature values are collected simultaneously from: Moni-Patch™ Sensor (neck placement) Esophageal core temperature probe (Teso) Bladder core temperature probe (Tbld) Agreement is evaluated using Bland-Altman analysis, including: Mean temperature difference (bias; °C) 95% limits of agreement (LOA; °C) Name of Measurement: Core temperature difference (Moni-Patch - Teso; Moni-Patch - Tbld) Measurement Tools: Moni-Patch™ Temperature Monitoring Patch System FDA-cleared esophageal core temperature monitor (Teso) FDA-cleared bladder core temperature monitor (Tbld) Unit of Measure: Degrees Celsius (°C)	Continuous intra-operative monitoring for ≥60 minutes, beginning after ≥30 minutes of Moni-Patch sensor acclimation prior to operating room entry.

Collaborators and Investigators

• Sponsor: Murata Vios, Inc.
• Collaborators: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): February 6, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MM-MPS2-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified device signal data may be shared upon reasonable request after publication, subject to data use agreement; no PHI will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No