HealthyPhase 4NCT02805322
Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice
A Phase 4 study testing ARC InstaTemp MD, Covidien Genius 2 Tympanic Thermometer and Welch Allen SureTemp Plus Sublingual Thermometer in people with Healthy and Febrile, run by ARC Devices at 1 site in Ireland.
Trial summary
Quantify the reliability and agreement of estimated core body temperature using the InstaTemp MD™ and other widely marketed reference Thermometers Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- ARC InstaTemp MD, Covidien Genius 2 Tympanic Thermometer and Welch Allen SureTemp Plus Sublingual Thermometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2016to Jun 2016
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any age
- Either gender
- Attending ED, outpatients or inpatient Departments of Cork University Hospital Campus
- Provision of informed consent or in case of minor's provision of age appropriate assent with informed consent of parent (legal guardian).
Who cannot join
- Those who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures
- Those who forehead cannot be fully exposed to the ambient conditions for at least 15 minutes
- Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site
- Subjects currently using cooling blankets or fans.
- Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, corticosteroids, alcoholic intoxication, documented illicit drug use or immunizations In the previous 5 days
- Any recent hot or cold drinks prior to a sub-lingual reading (i.e. 15min before measurement)
- Those participating in a clinical trial of an investigational medicinal product
Trial locations and contacts
1 site in 1 country.
About this study
Quantify the reliability and agreement of estimated core body temperature using the InstaTemp MD™ and other widely marketed reference Thermometers
Read the detailed description
This is a cross sectional Clinical Investigation in order to quantify the reliability and agreement of estimated core body temperature using emitted surface body heat measured by the InstaTemp MD™ Non-Touch thermometer when compared to other widely marketed reference Thermometers
- Being tested
- ARC InstaTemp MD, Covidien Genius 2 Tympanic Thermometer, Welch Allen SureTemp Plus Sublingual Thermometer
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC InstaTemp MDDevice
Measurement of Body Temperature using an Infrared Non-Touch Thermometer - Experimental arm.
Covidien Genius 2 Tympanic ThermometerDevice
Measurement of Tympanic Temperature using a standard approved method - Control arm.
Welch Allen SureTemp Plus Sublingual ThermometerDevice
Measurement of Sublingual Temperature using a standard approved method - Control arm.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Temperature Measurement | Experimental | Infrared Temporal Temperature Measurement using the ARC InstaTemp MD in three different age groups with a specified percentage reporting as febrile. Receives: Device: ARC InstaTemp MD |
| Tympanic and/or Sublingual Temperature | Active comparator | Tympanic and/or Sublingual Temperature Measurement using one or both of two widely used reference clinical thermometers in three different age groups with a specified percentage reporting as febrile.
Choice between Tympanic and/or Sublingual is determined based on standard of care in study site
Reference Thermometer 1 - Covidien Genius 2 Tympanic Thermometer
Reference Thermometer 2 - Welch Allen SureTemp Plus Sublingual Thermometer Receives: Device: Covidien Genius 2 Tympanic Thermometer; Device: Welch Allen SureTemp Plus Sublingual Thermometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Bias
Mean Bias (95% Levels of agreement) between ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device and (a) the Covidien Tympanic thermometer and (b) the Welch Allyn thermometer at an oral or axillary site as appropriate to subjects' age and clinical circumstance.
Measured: Baseline temperature measurement using all relevant interventions
Reproducibility
Overall reproducibility of ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device.
Measured: Baseline measurement of 3 temperature reading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARC Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cork University Hospital
- Responsible party
- Sponsor
- Investigators
- Joe Eustace, Prof, Principal investigator, Cork University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805322
- Sponsor's protocol ID
- ARC-CRFC-03
- Status last verified
- Jun 2016
- First submitted
- 9 Jun 2016
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT02805322
- Acronym / sponsor ID
- ARC-CRFC-03
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- ARC DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Cork University Hospital
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Jun 2016 (estimated)
- 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.
Quantify the reliability and agreement of estimated core body temperature using the InstaTemp MD™ and other widely marketed reference Thermometers
Detailed description
This is a cross sectional Clinical Investigation in order to quantify the reliability and agreement of estimated core body temperature using emitted surface body heat measured by the InstaTemp MD™ Non-Touch thermometer when compared to other widely marketed reference Thermometers
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporal Temperature Measurement | Experimental | Device: ARC InstaTemp MDInfrared Temporal Temperature Measurement using the ARC InstaTemp MD in three different age groups with a specified percentage reporting as febrile. |
| Tympanic and/or Sublingual Temperature | Active comparator | Device: Covidien Genius 2 Tympanic Thermometer, Device: Welch Allen SureTemp Plus Sublingual ThermometerTympanic and/or Sublingual Temperature Measurement using one or both of two widely used reference clinical thermometers in three different age groups with a specified percentage reporting as febrile. Choice between Tympanic and/or Sublingual is determined based on standard of care in study site Reference Thermometer 1 - Covidien Genius 2 Tympanic Thermometer Reference Thermometer 2 - Welch Allen SureTemp Plus Sublingual Thermometer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Any age
- Either gender
- Attending ED, outpatients or inpatient Departments of Cork University Hospital Campus
- Provision of informed consent or in case of minor's provision of age appropriate assent with informed consent of parent (legal guardian).
Key exclusion criteria (7 listed)
- Those who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures
- Those who forehead cannot be fully exposed to the ambient conditions for at least 15 minutes
- Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site
- Subjects currently using cooling blankets or fans.
- Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, corticosteroids, alcoholic intoxication, documented illicit drug use or immunizations In the previous 5 days
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 |
|---|---|---|
| ARC InstaTemp MDMeasurement of Body Temperature using an Infrared Non-Touch Thermometer - Experimental arm. | Device | Temporal Temperature Measurement |
| Covidien Genius 2 Tympanic ThermometerMeasurement of Tympanic Temperature using a standard approved method - Control arm. | Device | Tympanic and/or Sublingual Temperature |
| Welch Allen SureTemp Plus Sublingual ThermometerMeasurement of Sublingual Temperature using a standard approved method - Control arm. | Device | Tympanic and/or Sublingual Temperature |
Primary outcome
Mean Bias
Time frame: Baseline temperature measurement using all relevant interventions
Mean Bias (95% Levels of agreement) between ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device and (a) the Covidien Tympanic thermometer and (b) the Welch Allyn thermometer at an oral or axillary site as appropriate to subjects' age and clinical circumstance.
Reproducibility
Time frame: Baseline measurement of 3 temperature reading
Overall reproducibility of ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device.
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 20 Jun 2016.
- 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.
Joe Eustace, Prof principal investigator
Cork University Hospital, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ARC InstaTemp MD, Covidien Genius 2 Tympanic Thermometer and Welch Allen SureTemp Plus Sublingual Thermometer in people with Healthy and Febrile, run by ARC Devices at 1 site in Ireland.
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 4 inclusion and 7 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 20 Jun 2016. 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 Ireland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean Bias (time frame: Baseline temperature measurement using all relevant interventions). The study lists 2 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 20 Jun 2016.