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..
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:
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- 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.
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.
- Conditions
- Temperature Monitoring, Intraoperative
- 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.
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.
- First posted9 Feb 2026
- Study start6 Feb 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Murata Vios, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moni-Patc Temperature Monitoring Patch System Clinical Accuracy Validation
- ClinicalTrials.gov ID
- NCT07397065
- Acronym / sponsor ID
- Moni-Patch OR / MM-MPS2-0001
- Conditions
- Temperature Monitoring, Intraoperative
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Murata Vios, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- 6 Feb 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moni-Patc Temperature Monitoring Patch SystemAlso: MP-P20U Sensor, MP-D20U Receiver, MP-S20U Disposable Strips, MP-E20U Extension CableA 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). | Device | – |
Primary outcome
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.
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No. De-identified device signal data may be shared upon reasonable request after publication, subject to data use agreement; no PHI will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.