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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Fever; Febrile Illness
• Intervention / Treatment: Device: NC° Thermometer (Gen 3)

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.

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

• Study Contact: Name: Megan Callanan; Phone Number: 2167444524; Email: megan.callanan@naturalcycles.com

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92804
      • Choice Health Network- Reyes Health Center
  • New York
    • New York, New York, United States, 10036
      • Natural Cycles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Natural Cycles

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever
• Other Study ID Numbers: 2023001 (SUN Yat-sen University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes