FeverNCT03758157
Clinical Accuracy of the welloStationX
An observational study of Fever, run by Wello Inc. at 1 site in United States.
Trial summary
This study evaluates the clinical accuracy of the welloStationX, an automated non-touch self-service electronic thermometer using an infrared sensor of the surface of the forehead to screen for fever. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fever
- What is being tested?
- welloStationX and SureTemp
- Type of treatment
- Pill or oral medicine
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 15 Nov 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects will be selected from amongst non-profit clinical sites and through social media posts for subjects to come to a test site or to be evaluated in his or her own home in the widespread Dallas/Fort Worth area.
Who may be able to join
- Male or female.
- 5 years and up.
- Signed informed consent form.
Who cannot join
- Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the test.
- immunization within seven days of the test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: welloStationX Determination of Clinical Accuracy
This study evaluates the clinical accuracy of the welloStationX, an automated non-touch self-service electronic thermometer using an infrared sensor of the surface of the forehead to screen for fever.
Read the detailed description
Traditionally, body temperature is measured using a contact thermometer placed on the forehead, in the mouth, ear, armpit or rectum. Non-contact thermometers allow a person's temperature to be taken with no contact with the person, reducing the discomfort of having to sit still for several minutes. Additionally, there is no need for disinfection between patients to occur, allowing for easier and faster use when screening large numbers of people.
This study is to evaluate the clinical accuracy of the welloStationX, a non-contact thermometer by comparing its measurements with that of the gold standard Welch Allyn SureTemp oral thermometer.
- Conditions
- Fever
- Being tested
- welloStationX, SureTemp
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
welloStationXDiagnostic test
welloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever.
SureTempDiagnostic test
SureTemp is an oral thermometer to measure human body skin temperature.
| Study group | Role | What they receive |
|---|---|---|
| Temperature Measurement | Each subject will have his or her temperature measured by both the welloStationX Automated Non-Contact Thermometer and the Welch Allyn SureTemp Oral Thermometer. Receives: Diagnostic Test: welloStationX; Diagnostic Test: SureTemp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Agreement Through Clinical Bias Evaluation
Agreement through clinical bias evaluation was calculated as the Mean Bias ± Standard Deviation (SD) by subtracting the first output measurement recorded with the welloStationX thermometer (DUT) from the corresponding output measurement recorded with the Welch Allyn SureTemp oral thermometer for each subject, and then calculating the Mean Bias ± SD of the biases.
Measured: one day
Secondary outcomes (1)
Clinical Repeatability
Clinical Repeatability was calculated using the pooled standard deviations of the triplicate measurements recorded by the welloStationX.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start15 Oct 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FeverStudies 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
- Other
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wello Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan C Heller, Study chair, Wello Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758157
- Sponsor's protocol ID
- Wello_X
- Status last verified
- Jun 2021
- First submitted
- 27 Nov 2018
- Last updated
- 7 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- welloStationX Determination of Clinical Accuracy
- ClinicalTrials.gov ID
- NCT03758157
- Acronym / sponsor ID
- Wello_X
- Conditions
- Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wello Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Posted 7 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the clinical accuracy of the welloStationX, an automated non-touch self-service electronic thermometer using an infrared sensor of the surface of the forehead to screen for fever.
Detailed description
Traditionally, body temperature is measured using a contact thermometer placed on the forehead, in the mouth, ear, armpit or rectum. Non-contact thermometers allow a person's temperature to be taken with no contact with the person, reducing the discomfort of having to sit still for several minutes. Additionally, there is no need for disinfection between patients to occur, allowing for easier and faster use when screening large numbers of people.
This study is to evaluate the clinical accuracy of the welloStationX, a non-contact thermometer by comparing its measurements with that of the gold standard Welch Allyn SureTemp oral thermometer.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temperature Measurement | – | Diagnostic Test: welloStationX, Diagnostic Test: SureTempEach subject will have his or her temperature measured by both the welloStationX Automated Non-Contact Thermometer and the Welch Allyn SureTemp Oral Thermometer. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be selected from amongst non-profit clinical sites and through social media posts for subjects to come to a test site or to be evaluated in his or her own home in the widespread Dallas/Fort Worth area.
Key inclusion criteria (3 listed)
- Male or female.
- 5 years and up.
- Signed informed consent form.
Key exclusion criteria (2 listed)
- Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the test.
- immunization within seven days of the test
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 |
|---|---|---|
| welloStationXwelloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever. | Diagnostic test | Temperature Measurement |
| SureTempSureTemp is an oral thermometer to measure human body skin temperature. | Diagnostic test | Temperature Measurement |
Primary outcome
Clinical Agreement Through Clinical Bias Evaluation
Time frame: one day
Agreement through clinical bias evaluation was calculated as the Mean Bias ± Standard Deviation (SD) by subtracting the first output measurement recorded with the welloStationX thermometer (DUT) from the corresponding output measurement recorded with the Welch Allyn SureTemp oral thermometer for each subject, and then calculating the Mean Bias ± SD of the biases.
1 secondary outcome
Clinical Repeatability
Time frame: one day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Alan C Heller study chair
Wello Inc.
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 Fever, run by Wello Inc. 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 3 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 7 Jul 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?
Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Agreement Through Clinical Bias Evaluation (time frame: one day). 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 7 Jul 2021.