What this study is
Simplified from ClinicalTrials.govTesting a non-invasive temperature patch placed on the neck (Moni-Patch Temperature Monitoring Patch System) to collect body temperature readings during surgery, to help develop its temperature estimation program, in adults 18 and older having elective surgery under general anesthesia.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- Moni-Patch Temperature Monitoring Patch System
Intervention · DEVICE
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 details
- Official title
- Moni-Patch Temperature Monitoring Patch System Algorithm Development Data Collection
- Sponsor
- Murata Vios, Inc.
- Conditions
- Body Temperature Monitoring
- Enrolling
- 30 people
- Starts
- 2026-10-03
- Est. completion
- 2027-04-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Minnesota Medical Center
Minneapolis, Minnesota, United States
Recruiting
Study team
Sponsor
Murata Vios, Inc.
Study ID MM-MPS2-0002
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.