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

NCT05721131 | Completed FDA Device

• 1 other identifier: 2023001
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Febrile Illness; Healthy; Fever

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Temperature measurement

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

Device: NC° Thermometer (Gen 3)

Interventions

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.

Temperature measurement

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be asked to participate and enrolled during standard visits to the medical clinic or office location.

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

Sponsors & Collaborators

• Natural Cycles: lead

Study Sites (2)

Choice Health Network- Reyes Health Center

Anaheim, California, 92804, United States

Location

Natural Cycles

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: January 10, 2023
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)