Clinical Accuracy Validation of the Moni-Patc Temperature Monitoring Patch During Surgery (Compar… (NCT07397065) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Accuracy Validation of the Moni-Patc Temperature Monitoring Patch During Surgery (Compared With Esophageal and Bladder Temperature)
30 participantsStarted 2026-02-06
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement Between Moni-Patch™ Temperature Monitoring Patch System and Esophageal (Teso) and Bladder (Tbld) Core Temperature Measurements
Timeframe: Continuous intra-operative monitoring for ≥60 minutes, beginning after ≥30 minutes of Moni-Patch sensor acclimation prior to operating room entry.
. 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.