Body Temperature MonitoringNCT07901296
Moni-Patch Temperature Data Collection for Algorithm Development During Surgery
A study testing Moni-Patch Temperature Monitoring Patch System in people with Body Temperature Monitoring, run by Murata Vios, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Temperature Monitoring
- What is being tested?
- Moni-Patch Temperature Monitoring Patch System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2026to 1 Apr 2027
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: Moni-Patch Temperature Monitoring Patch System Algorithm Development Data Collection
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.
Read more
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.
Read the detailed description
This is a prospective, single-center study designed to collect synchronized Moni-Patch and esophageal temperature data for algorithm development and refinement.
Approximately 30 adult patients undergoing elective surgery under general anesthesia lasting at least 120 minutes will be enrolled.
A Moni-Patch sensor will be attached to the skin over the carotid artery in the neck. The sensor will communicate wirelessly with a PC-based data logger to continuously record temperature measurements and device data.
Esophageal temperature will be monitored using a clinically indicated temperature probe connected to the patient monitoring system.
Synchronized temperature data will be collected during surgery. At least 120 minutes of valid simultaneous Moni-Patch and esophageal temperature measurements will be targeted for each participant.
Data collection will also include patient characteristics, surgical and anesthesia information, warming conditions, device-use information, and relevant environmental conditions.
The collected data will be used to identify opportunities for algorithm improvement and to characterize device performance internally. Descriptive analyses may be performed, but no formal clinical accuracy hypothesis test or pass/fail acceptance criterion is planned.
Moni-Patch readings will not be used to guide clinical care.
- Conditions
- Body Temperature Monitoring
- Being tested
- Moni-Patch Temperature Monitoring Patch System
- Keywords
- Moni-Patch, Core Body Temperature, Esophageal Temperature, Algorithm Development, General Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moni-Patch Temperature Monitoring Patch SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Moni-Patch Temperature Data Collection | Experimental | 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. Receives: Device: Moni-Patch Temperature Monitoring Patch System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Evaluable Synchronized Moni-Patch and Esophageal Temperature Data
The number of participants with at least 120 minutes of valid simultaneous Moni-Patch and esophageal temperature measurements collected during surgery.
Data will be used for algorithm development, refinement, and descriptive evaluation. No formal clinical accuracy hypothesis testing or pass/fail acceptance criteria will be applied.
Time Frame: During surgery, targeting at least 120 minutes of simultaneous temperature monitoring per participant.
Important: This is a proposed operational data-collection outcome for ClinicalTrials.gov registration. The protocol does not formally designate a primary clinical outcome. The wording should be confirmed with the Sponsor and study team before submission.
Measured: During surgery, targeting at least 120 minutes of simultaneous temperature monitoring per participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start3 Oct 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT07901296
- Sponsor's protocol ID
- MM-MPS2-0002
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant-level data are intended for internal algorithm development and refinement. No public IPD-sharing plan is specified in the protocol.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moni-Patch Temperature Monitoring Patch System Algorithm Development Data Collection
- ClinicalTrials.gov ID
- NCT07901296
- Acronym / sponsor ID
- MM-MPS2-0002
- Conditions
- Body Temperature Monitoring
- Keywords
- Moni-Patch, Core Body Temperature, Esophageal Temperature, Algorithm Development, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Murata Vios, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- 3 Oct 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 28 Oct 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.
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.
Detailed description
This is a prospective, single-center study designed to collect synchronized Moni-Patch and esophageal temperature data for algorithm development and refinement.
Approximately 30 adult patients undergoing elective surgery under general anesthesia lasting at least 120 minutes will be enrolled.
A Moni-Patch sensor will be attached to the skin over the carotid artery in the neck. The sensor will communicate wirelessly with a PC-based data logger to continuously record temperature measurements and device data.
Esophageal temperature will be monitored using a clinically indicated temperature probe connected to the patient monitoring system.
Synchronized temperature data will be collected during surgery. At least 120 minutes of valid simultaneous Moni-Patch and esophageal temperature measurements will be targeted for each participant.
Data collection will also include patient characteristics, surgical and anesthesia information, warming conditions, device-use information, and relevant environmental conditions.
The collected data will be used to identify opportunities for algorithm improvement and to characterize device performance internally. Descriptive analyses may be performed, but no formal clinical accuracy hypothesis test or pass/fail acceptance criterion is planned.
Moni-Patch readings will not be used to guide clinical care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moni-Patch Temperature Data Collection | Experimental | Device: Moni-Patch Temperature Monitoring Patch SystemParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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-Patch Temperature Monitoring Patch SystemA 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. | Device | Moni-Patch Temperature Data Collection |
Primary outcome
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.
The number of participants with at least 120 minutes of valid simultaneous Moni-Patch and esophageal temperature measurements collected during surgery. Data will be used for algorithm development, refinement, and descriptive evaluation. No formal clinical accuracy hypothesis testing or pass/fail acceptance criteria will be applied. Time Frame: During surgery, targeting at least 120 minutes of simultaneous temperature monitoring per participant. Important: This is a proposed operational data-collection outcome for ClinicalTrials.gov registration. The protocol does not formally designate a primary clinical outcome. The wording should be confirmed with the Sponsor and study team before submission.
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 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant-level data are intended for internal algorithm development and refinement. No public IPD-sharing plan is specified in the protocol.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moni-Patch Temperature Monitoring Patch System in people with Body Temperature Monitoring, run by Murata Vios, Inc. at 1 site in United States.
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 7 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (6124977397, a.shibata@murata.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). 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 28 Oct 2026.