NCT04968080CompletedNot Applicable
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
Infrared Cameras Incorporate1 site in 1 country887 target enrollmentStarted: May 3, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 887
- Locations
- 1
- Primary Endpoint
- Average Ear Thermometer Body Temperature
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants must be able to provide opt-out consent.
- •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
- •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.
- •Participants who are not able to understand that their temperature will be recorded, or who are otherwise unwilling to participate.
Outcomes
Primary Outcomes
Average Ear Thermometer Body Temperature
Time Frame: Up to Week 4
Forehead Thermometer Body Temperature
Time Frame: Up to Week 4
Infrared Thermal Camera (IRT) Calculated Human Body Temperature
Time Frame: Up to Week 4
Average Oral Thermometer Body Temperature
Time Frame: Up to Week 4
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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