A Study to Validate Comparability of an Infrared Thermographic Camera Versus Oral, Forehead, and Ear Thermometers When Determining Body Temperature in Adult Participants
NCT04968080 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 887
Last updated 2021-09-16
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.
Conditions
- Temperature Change, Body
Interventions
- DEVICE
-
Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System
Infrared thermal camera
- DEVICE
-
Welch Allyn SureTemp Plus 690
Oral thermometer
- DEVICE
-
Welch Allyn ThermoScan PRO 6000
Ear thermometer
- DEVICE
-
Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer
Forehead temperature gun
Sponsors & Collaborators
-
Infrared Cameras Incorporate
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-05-03
- Primary Completion
- 2021-08-17
- Completion
- 2021-08-17
- FDA Device
- Yes
Countries
- United States
Study Locations
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