Trial Outcomes & Findings for Clinical Accuracy of the welloStationX (NCT NCT03758157)
NCT ID: NCT03758157
Last Updated: 2021-07-07
Results Overview
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.
COMPLETED
110 participants
one day
2021-07-07
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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110
|
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Overall Study
COMPLETED
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110
|
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Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Accuracy of the welloStationX
Baseline characteristics by cohort
| Measure |
Temperature Measurement
n=110 Participants
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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|---|---|
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Age, Continuous
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44.78 years
STANDARD_DEVIATION 16.14 • n=99 Participants
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Sex: Female, Male
Female
|
74 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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36 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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54 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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56 Participants
n=99 Participants
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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110 Participants
n=99 Participants
|
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febrility
febrile subjects (temperature >=99.5 deg. C)
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33 Participants
n=99 Participants
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febrility
afebrile subjects (temperature < 99.5 deg. C)
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77 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: one dayAgreement 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.
Outcome measures
| Measure |
Temperature Measurement
n=110 Participants
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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|---|---|
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Clinical Agreement Through Clinical Bias Evaluation
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0.04 degrees Farehheit
Standard Deviation 0.42
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SECONDARY outcome
Timeframe: one dayClinical Repeatability was calculated using the pooled standard deviations of the triplicate measurements recorded by the welloStationX.
Outcome measures
| Measure |
Temperature Measurement
n=110 Participants
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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Clinical Repeatability
|
0.062 degrees Farehheit
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Adverse Events
Temperature Measurement
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place