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OpenTrials
Completed

NCT Number: NCT04968080

A Study to Validate Comparability of an Infrared Thermographic Camera Versus Oral, Forehead, and Ear Thermometers When Determining Body Temperature in Adult Participants

The primary objective of this study is to determine if the Infrared Cameras, Inc (ICI) FMX 400 infrared (IR) Class 1 infrared thermal camera (IRT) system is comparable to oral, forehead, and ear thermometers for determining human body temperature.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

PRA Health Sciences - Early Development Services

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be able to provide opt-out consent.
  • Participants must agree to have temperature recorded noninvasively using an infrared thermal camera (IRT) Class 1 device, oral thermometer, forehead thermometer, and ear thermometer.

Exclusion criteria

  • Participants who opt out of participating; ie, participants who do not agree to have temperature recorded noninvasively using an IRT Class 1 device, oral thermometer, forehead thermometer, and ear thermometer.
  • Participants who are not able to understand that their temperature will be recorded, or who are otherwise unwilling to participate.

Treatment and study plan

Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System

Device

Infrared thermal camera

Welch Allyn SureTemp Plus 690

Device

Oral thermometer

Welch Allyn ThermoScan PRO 6000

Device

Ear thermometer

Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer

Device

Forehead temperature gun

Primary outcomes

  1. Infrared Thermal Camera (IRT) Calculated Human Body Temperature

    Time frame: Up to Week 4

  2. Average Oral Thermometer Body Temperature

    Time frame: Up to Week 4

  3. Forehead Thermometer Body Temperature

    Time frame: Up to Week 4

  4. Average Ear Thermometer Body Temperature

    Time frame: Up to Week 4

Sponsors and collaborators

Lead sponsor

Infrared Cameras Incorporate

Industry

Registry information

Official study title

Prospective, Observational, Single-Arm Study to Validate Comparability of an Infrared Thermographic Camera Versus Oral, Forehead, and Ear Thermometers When Determining Body Temperature in Anonymous Adult Participants

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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