NCT03758157

Clinical Accuracy of the welloStationX

Completed Results posted Last updated 7 July 2021

What this trial tests

trial testing welloStationX in Fever in 110 participants. Completed in 15 November 2018.

Timeline

15 October 2018

Primary endpoint
15 November 2018

15 November 2018

Quick facts

Lead sponsor	Wello Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	110
Start date	15 October 2018
Primary completion	15 November 2018
Estimated completion	15 November 2018
Sites	1 location across United States

Drugs / interventions tested

• welloStationX
• SureTemp

Conditions studied

• Fever — all drugs for Fever →

Sponsor

Wello Inc.

Who can join

5 and older, any sex, with Fever. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Agreement Through Clinical Bias Evaluation Primary · 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.

Group	Value	95% CI
Temperature Measurement	0.04	± 0.42

Clinical Repeatability Secondary · one day

Clinical Repeatability was calculated using the pooled standard deviations of the triplicate measurements recorded by the welloStationX.

Group	Value	95% CI
Temperature Measurement	0.062

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.