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NCT04968080 Clinical Trial

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

Temperature Change, Body Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04968080
Other study ID # ICI IRT V 001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 3, 2021
Est. completion date August 17, 2021

Study information
Verified date September 2021
Source Infrared Cameras Incorporate
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 887
Est. completion date August 17, 2021
Est. primary completion date August 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System
Infrared thermal camera
• Welch Allyn SureTemp Plus 690
Oral thermometer
• Welch Allyn ThermoScan PRO 6000
Ear thermometer
• Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer
Forehead temperature gun

Locations
Country Name City State
United States PRA Health Sciences - Early Development Services Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Infrared Cameras Incorporate

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Infrared Thermal Camera (IRT) Calculated Human Body Temperature Up to Week 4
Primary Average Oral Thermometer Body Temperature Up to Week 4
Primary Forehead Thermometer Body Temperature Up to Week 4
Primary Average Ear Thermometer Body Temperature Up to Week 4
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