Temperature Change, BodyNCT04968080
A Study to Validate Comparability of an Infrared Thermographic Camera Versus Oral, Forehead, and Ear Thermometers When Determining Body Temperature in Adult Participants
An observational study of Temperature Change, Body, run by Infrared Cameras Incorporate at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System, Welch Allyn SureTemp Plus 690 and Welch Allyn ThermoScan PRO 6000
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 887 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 17 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
PRA Health Sciences - Early Development Services
Salt Lake City, Utah, 84124
About this study
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
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.
- Conditions
- Temperature Change, Body
- Being tested
- 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
- Keywords
- Infrared Thermal Camera, IRT
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera SystemDevice
Infrared thermal camera
Welch Allyn SureTemp Plus 690Device
Oral thermometer
Welch Allyn ThermoScan PRO 6000Device
Ear thermometer
Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared ThermometerDevice
Forehead temperature gun
| Study group | Role | What they receive |
|---|---|---|
| Full Analysis Set | Participants will have their temperature collected by infrared thermal camera (IRT), oral, forehead, and ear thermometers. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infrared Thermal Camera (IRT) Calculated Human Body Temperature
Measured: Up to Week 4
Average Oral Thermometer Body Temperature
Measured: Up to Week 4
Forehead Thermometer Body Temperature
Measured: Up to Week 4
Average Ear Thermometer Body Temperature
Measured: Up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start3 May 2021
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 887 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infrared Cameras Incorporate
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968080
- Sponsor's protocol ID
- ICI IRT V 001
- Status last verified
- Sep 2021
- First submitted
- 13 Jul 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04968080
- Acronym / sponsor ID
- ICI IRT V 001
- Conditions
- Temperature Change, Body
- Keywords
- Infrared Thermal Camera, IRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 887 participants (actual)
- Lead sponsor
- Infrared Cameras IncorporateIndustry (pharma, biotech, devices)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full Analysis Set | – | 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 ThermometerParticipants will have their temperature collected by infrared thermal camera (IRT), oral, forehead, and ear thermometers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera SystemInfrared thermal camera | Device | Full Analysis Set |
| Welch Allyn SureTemp Plus 690Oral thermometer | Device | Full Analysis Set |
| Welch Allyn ThermoScan PRO 6000Ear thermometer | Device | Full Analysis Set |
| Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared ThermometerForehead temperature gun | Device | Full Analysis Set |
Primary outcome
Infrared Thermal Camera (IRT) Calculated Human Body Temperature
Time frame: Up to Week 4
Average Oral Thermometer Body Temperature
Time frame: Up to Week 4
Forehead Thermometer Body Temperature
Time frame: Up to Week 4
Average Ear Thermometer Body Temperature
Time frame: Up to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperature Change, Body, run by Infrared Cameras Incorporate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infrared Thermal Camera (IRT) Calculated Human Body Temperature (time frame: Up to Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.