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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Temperature Change, Body

Intervention / Treatment
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* Device: Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System
* Device: Welch Allyn SureTemp Plus 690
* Device: Welch Allyn ThermoScan PRO 6000
* Device: Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Full Analysis Set<br>Participants will have their temperature collected by infrared thermal camera (IRT), oral, forehead, and ear thermometers. | Device: Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System<br>* Infrared thermal camera<br>Device: Welch Allyn SureTemp Plus 690<br>* Oral thermometer<br>Device: Welch Allyn ThermoScan PRO 6000<br>* Ear thermometer<br>Device: Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer<br>* Forehead temperature gun<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infrared Thermal Camera (IRT) Calculated Human Body Temperature |  | Up to Week 4 | 
| Average Oral Thermometer Body Temperature |  | Up to Week 4 | 
| Forehead Thermometer Body Temperature |  | Up to Week 4 | 
| Average Ear Thermometer Body Temperature |  | Up to Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IRT, Infrared Thermal Camera