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

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.

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Key information

Conditions

Febrile Illness Body Temperature Changes Fever Healthy Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Choice Health Network- Reyes Health Center, Anaheim, California, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NC° Thermometer (Gen 3)

Device

The NC° Thermometer (Gen3) is used orally for the intermittent measurement and monitoring of human body temperature. The device can be used by adults and children over the age of 5 years old.

Primary outcomes

Clinical Bias

Time frame: 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.
Limits of agreement

Time frame: 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.
Clinical repeatability

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Natural Cycles

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Feb 9, 2023
Registry last updated: Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed