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

NCT ID: NCT04968080

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

887 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-03

Study Completion Date

2021-08-17

Brief Summary

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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.

Detailed Description

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Conditions

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Temperature Change, Body

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Full Analysis Set

Participants will have their temperature collected by infrared thermal camera (IRT), oral, forehead, and ear thermometers.

Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System

Intervention Type DEVICE

Infrared thermal camera

Welch Allyn SureTemp Plus 690

Intervention Type DEVICE

Oral thermometer

Welch Allyn ThermoScan PRO 6000

Intervention Type DEVICE

Ear thermometer

Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer

Intervention Type DEVICE

Forehead temperature gun

Interventions

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Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System

Infrared thermal camera

Intervention Type DEVICE

Welch Allyn SureTemp Plus 690

Oral thermometer

Intervention Type DEVICE

Welch Allyn ThermoScan PRO 6000

Ear thermometer

Intervention Type DEVICE

Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer

Forehead temperature gun

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Infrared Cameras Incorporate

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PRA Health Sciences - Early Development Services

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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ICI IRT V 001

Identifier Type: -

Identifier Source: org_study_id

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