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

September 15, 2021 updated by: Infrared Cameras Incorporate

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

887

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • PRA Health Sciences - Early Development Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Full Analysis Set
Participants will have their temperature collected by infrared thermal camera (IRT), oral, forehead, and ear thermometers.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infrared Thermal Camera (IRT) Calculated Human Body Temperature
Time Frame: Up to Week 4
Up to Week 4
Average Oral Thermometer Body Temperature
Time Frame: Up to Week 4
Up to Week 4
Forehead Thermometer Body Temperature
Time Frame: Up to Week 4
Up to Week 4
Average Ear Thermometer Body Temperature
Time Frame: Up to Week 4
Up to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infrared Cameras Incorporate

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Actual)

August 17, 2021

Study Completion (Actual)

August 17, 2021

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICI IRT V 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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