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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| welloStationX | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one day |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Repeatability | Clinical Repeatability was calculated using the pooled standard deviations of the triplicate measurements recorded by the welloStationX. | one day |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Alan C Heller | Wello Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agape Clinic | Dallas | Texas | 75246 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | welloStationX Automated Non-Contact Thermometer | welloStationX: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Temperature Measurement | welloStationX: 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. SureTemp: SureTemp is an oral thermometer to measure human body skin temperature. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | degrees Farehheit | one day |
|
|
One day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. welloStationX: 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. SureTemp: SureTemp is an oral thermometer to measure human body skin temperature. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan C. Heller | Wello, Inc. | 469-522-5200 | allen.heller@welloinc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2018 | Jun 14, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2018 | Jun 14, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| SureTemp | Diagnostic Test | SureTemp is an oral thermometer to measure human body skin temperature. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| febrility | Count of Participants | Participants |
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| Counts |
|---|
| Participants |
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| Secondary | Clinical Repeatability | Clinical Repeatability was calculated using the pooled standard deviations of the triplicate measurements recorded by the welloStationX. | Posted | Number | degrees Farehheit | one day |
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| 0 |
| 110 |
| 0 |
| 110 |
| 0 |
| 110 |
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