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Temperature MonitoringMoni-Patch ORNCT07397065

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

An observational study of Temperature Monitoring and Intraoperative, run by Murata Vios, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Temperature Monitoring, Intraoperative
What is being tested?
Moni-Patc Temperature Monitoring Patch System
Type of treatment
Medical device
How many people
30 participants
Where
No sites listed yet
Study dates
6 Feb 2026to 30 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Age ≥18 years
  • 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.
  • Subjects are expected to remain hospitalized at least overnight after surgery.
  • Subject specifically agrees to temperature Sensor placement on the neck prior to surgery.
  • 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).
  • Use environment must meet both of the following parameters:
Show all 9Show fewer
  • Temperature 15-40⁰ C/59-104⁰ F
  • Humidity 30-75% RH (non-condensing)
  • For non-English speaking subjects, a translator must be present at the time of consent.

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ash Shibata Senior Manager contact

612-497-7397

a.shibata@murata.com

About this study

Official title: 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.

Read the 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.

Being tested
Moni-Patc Temperature Monitoring Patch System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moni-Patc Temperature Monitoring Patch SystemDevice

    Also called MP-P20U Sensor, MP-D20U Receiver, MP-S20U Disposable Strips, MP-E20U Extension Cable

    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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Continuous intra-operative monitoring for ≥60 minutes, beginning after ≥30 minutes of Moni-Patch sensor acclimation prior to operating room entry.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start6 Feb 2026 (estimated)
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397065
Sponsor's protocol ID
MM-MPS2-0001
Acronym
Moni-Patch OR
Status last verified
Feb 2026
First submitted
28 Jan 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: De-identified device signal data may be shared upon reasonable request after publication, subject to data use agreement; no PHI will be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Temperature Monitoring and Intraoperative, run by Murata Vios, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ash Shibata Senior Manager (612-497-7397, a.shibata@murata.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement Between Moni-Patch™ Temperature Monitoring Patch System and Esophageal (Teso) and Bladder (Tbld) Core Temperature Measurements (time frame: Continuous intra-operative monitoring for ≥60 minutes, beginning after ≥30 minutes of Moni-Patch sensor acclimation prior to operating room entry.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07397065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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