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

I

Infrared Cameras Incorporate

Status

Completed

Conditions

Temperature Change, Body

Treatments

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

Study type

Observational

Funder types

Industry

Identifiers

NCT04968080
ICI IRT V 001

Details and patient eligibility

About

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.

Enrollment

887 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Participants must be able to provide opt-out consent.
  2. 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

  1. 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.
  2. Participants who are not able to understand that their temperature will be recorded, or who are otherwise unwilling to participate.

Trial design

887 participants in 1 patient group

Full Analysis Set
Description:
Participants will have their temperature collected by infrared thermal camera (IRT), oral, forehead, and ear thermometers.
Treatment:
Device: Welch Allyn ThermoScan PRO 6000
Device: Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System
Device: Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer
Device: Welch Allyn SureTemp Plus 690

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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