NCT05721131

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 105 (actual)
• Sponsor: Natural Cycles · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: —

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.

Conditions

• Febrile Illness
• Healthy
• Fever

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-10
• Primary completion: 2023-04-27
• Completion: 2023-04-27
• First posted: 2023-02-09
• Last updated: 2023-10-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study