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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04968080

Enrollment

887

Registered

2021-07-20

Start date

2021-05-03

Completion date

2021-08-17

Last updated

2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temperature Change, Body

Keywords

Infrared Thermal Camera, IRT

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.

Interventions

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

Infrared thermal camera

DEVICEWelch Allyn SureTemp Plus 690

Oral thermometer

DEVICEWelch Allyn ThermoScan PRO 6000

Ear thermometer

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

Forehead temperature gun

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026