A Study to Validate Comparability of an Infrared Thermogr... | NCT04968080

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

NCT04968080

Sponsor

Infrared Cameras Incorporate

Status

Completed

Last Update Posted

Sep 16, 2021Actual

Enrollment

887Actual

Phase

Not provided

Conditions

Temperature Change, Body

Interventions

Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System
Welch Allyn SureTemp Plus 690
Welch Allyn ThermoScan PRO 6000
Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 3, 2021Actual

Primary Completion Date

Aug 17, 2021Actual

Completion Date

Aug 17, 2021Actual

First Submitted Date

Jul 13, 2021

First Submission Date that Met QC Criteria

Jul 19, 2021

First Posted Date

Jul 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2021

Last Update Posted Date

Sep 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

887Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 Device: Welch Allyn SureTemp Plus 690 Device: Welch Allyn ThermoScan PRO 6000 Device: Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System	Device	Infrared thermal camera	Full Analysis Set

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PRA Health Sciences - Early Development Services		Salt Lake City	Utah	84124	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms