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

Completed

• Conditions: Temperature Change, Body
• Interventions: 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

• Registration Number: NCT04968080
• Lead Sponsor: Infrared Cameras Incorporate

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-03
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-20
• Primary Completion: 2021-08-17
• Study Completion: 2021-08-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 887

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Average Ear Thermometer Body Temperature	Up to Week 4
Forehead Thermometer Body Temperature	Up to Week 4
Infrared Thermal Camera (IRT) Calculated Human Body Temperature	Up to Week 4
Average Oral Thermometer Body Temperature	Up to Week 4

Trial Locations

Locations (1)

PRA Health Sciences - Early Development Services; 🇺🇸 Salt Lake City, Utah, United States