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

Natural Cycles

Status: Completed

Conditions: Fever; Healthy; Febrile Illness

Treatments: Device: NC° Thermometer (Gen 3)

Study type: Observational

Funder types: Industry

Identifiers

NCT05721131

2023001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

105 participants in 1 patient group

Temperature measurement

Description:

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

Treatment:

Device: NC° Thermometer (Gen 3)