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
1 other identifier
observational
887
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2021
CompletedFirst Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
July 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2021
CompletedSeptember 16, 2021
September 1, 2021
4 months
July 13, 2021
September 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
Full Analysis Set
Participants will have their temperature collected by infrared thermal camera (IRT), oral, forehead, and ear thermometers.
Interventions
Infrared thermal camera
Forehead temperature gun
Eligibility Criteria
Adult participants entering the PRA Health Sciences - Early Development Services (PRA-EDS) Salt Lake City business location who agree to receive anonymous infrared thermal camera (IRT) Class 1 device temperature scan while undergoing routine temperature surveillance.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Sciences - Early Development Services
Salt Lake City, Utah, 84124, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2021
First Posted
July 20, 2021
Study Start
May 3, 2021
Primary Completion
August 17, 2021
Study Completion
August 17, 2021
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share