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 range18 Years
SexALL
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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:
✓. Temperature 15-40⁰ C/59-104⁰ F
✓. Humidity 30-75% RH (non-condensing)
Exclusion criteria
✕. Subjects unable to provide their own consent. Consent from family or LOR is not acceptable.
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 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.