An observational study in Temperature Monitoring and Intraoperative, sponsored by Murata Vios, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Murata Vios, Inc. · Observational
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.
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.
Murata Vios, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Use environment must meet both of the following parameters:
Exclusion Criteria:
A non-sterile, non-invasive temperature monitoring system applied to the neck; Bluetooth 5.0 transmission to a receiver; continuous core temperature estimation using dual heat-flux/thermistor-based algorithm; conforms to ISO 80601-2-56 (25-42 °C).
Also known as: MP-P20U Sensor, MP-D20U Receiver, MP-S20U Disposable Strips, MP-E20U Extension Cable
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)
Time frame: Continuous intra-operative monitoring for ≥60 minutes, beginning after ≥30 minutes of Moni-Patch sensor acclimation prior to operating room entry.
No study locations are listed for this record.
Plan to share: No — De-identified device signal data may be shared upon reasonable request after publication, subject to data use agreement; no PHI will be shared.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Murata Vios, Inc.