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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05721131
• Other study ID #: 2023001
• Status: Completed
• Start date: January 10, 2023
• Est. completion date: April 27, 2023

Study information

• Verified date: October 2023
• Source: Natural Cycles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 27, 2023
• Est. primary completion date: April 27, 2023
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Febrile Illness
• Fever
• Healthy

Intervention

Device:
• NC° Thermometer (Gen 3)
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.

Locations

Country	Name	City	State
United States	Choice Health Network- Reyes Health Center	Anaheim	California
United States	Natural Cycles	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Natural Cycles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Bias	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.	Up to 1 hour
Primary	Limits of agreement	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.	Up to 1 hour
Primary	Clinical repeatability	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.	Up to 1 hour