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

• Sponsor: Infrared Cameras Incorporate (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04968080
• Collaborator: (none)
• Enrollment: 887
• Location: 1
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 254.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Temperature Change, Body	Device: Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System; Device: Welch Allyn SureTemp Plus 690; Device: Welch Allyn ThermoScan PRO 6000; Device: Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer

Study Design

• Study Type: Observational
• Actual Enrollment: 887 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: May 3, 2021
• Actual Primary Completion Date: Aug 17, 2021
• Actual Study Completion Date: Aug 17, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Infrared Thermal Camera (IRT) Calculated Human Body Temperature [Up to Week 4]

2. Average Oral Thermometer Body Temperature [Up to Week 4]

3. Forehead Thermometer Body Temperature [Up to Week 4]

4. Average Ear Thermometer Body Temperature [Up to Week 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences - Early Development Services	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

• Infrared Cameras Incorporate

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Infrared Cameras Incorporate
• ClinicalTrials.gov Identifier: NCT04968080
• Other Study ID Numbers: ICI IRT V 001
• First Posted: Jul 20, 2021
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Infrared Cameras Incorporate: Infrared Thermal Camera; IRT
• Additional relevant MeSH terms: Body Temperature Changes

Study Results

No Results Posted as of Sep 16, 2021