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

Completed

Conditions studied: Febrile Illness, Healthy, Fever

In brief

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.

Key facts

Study ID

NCT05721131

Run by

Natural Cycles

People needed

105

Starts

2023-01-10

Expected to finish

2023-04-27

Last updated by the study team

2023-10-30

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Choice Health Network- Reyes Health Center — Anaheim, California, United States
• Natural Cycles — New York, New York, United States

Full record on ClinicalTrials.gov

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