NC Thermometer (Gen 3) ISO 80601-2-56 Validation

Completed

• Conditions: Healthy; Fever; Febrile Illness
• Interventions: Device: NC° Thermometer (Gen 3)

• Registration Number: NCT05721131
• Lead Sponsor: Natural Cycles

Brief Summary

The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a reference clinical thermometer.

Detailed Description

The purpose of this clinical study is to validate the clinical accuracy of the NC° Thermometer (Gen 3) according to the requirements of ISO 80601-2-56:2017. The NC° Thermometer (Gen 3) (the device under study (DUT)) is a predictive thermometer that operates in adjusted mode. The Welch Allyn oral thermometer (Welch Allyn Spot Vital Signs 420 SureTemp temperature module, Welch Allyn, San Diego, CA) with a measurement accuracy of ± 0.1 °C in monitor mode will be used the reference clinical thermometer (RCT). During the clinical study, subjects will be asked to perform three consecutive oral measurements with the DUT, and one oral measurement with the RCT.

Study Timeline

• Study Start: 2023-01-10
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Primary Completion: 2023-04-27
• Study Completion: 2023-04-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• They are more than 5 years old
• They have not taken any antipyretic in the preceding 120 minutes
• They have no medical conditions which might impact the clinical accuracy validation results, such as inflammation at the measuring site (the mouth)
• They are not taking medications such as barbiturates, thyroid preparations, antipsychotics, and recent immunizations

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Temperature measurement	NC° Thermometer (Gen 3)	Each subject will have their temperature measured by both the NC° Thermometer (Gen 3) and the reference clinical thermometer.

Primary Outcome Measures

Name	Time	Method
Clinical Bias	Up to 1 hour	Clinical bias is the mean difference between the output temperatures of the NC° Thermometer (Gen 3) (DUT) and the reference clinical thermometer (RCT) for a specific reference body site (the mouth) when measured from a selected group of subjects. The clinical bias of the DUT defines closeness between the DUT output temperature and that of the RCT.
Clinical repeatability	Up to 1 hour	Clinical repeatability (sometimes called the perceived accuracy) is a measure of the consistency of repeated measurements with identical operating conditions when temperatures are taken within short time intervals from the same measuring site of the same subject by the same operator with the same intermittent clinical thermometer. Clinical repeatability is a pooled standard deviation of triplicate measurements over the population of subjects.
Limits of agreement	Up to 1 hour	Dispersion of output temperatures around the clinical bias can be estimated by the standard deviation of the temperature differences between the DUT and the RCT as measured from multiple subjects.

Trial Locations

Locations (2)

Choice Health Network- Reyes Health Center; 🇺🇸 Anaheim, California, United States

Natural Cycles; 🇺🇸 New York, New York, United States