NCT03758157

Clinical Accuracy of the welloStationX

welloStationX Determination of Clinical Accuracy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Wello Inc. · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	SureTemp	SureTemp is an oral thermometer to measure human body skin temperature.

Timeline

• Start date: 2018-10-15
• Primary completion: 2018-11-15
• Completion: 2018-11-15
• First posted: 2018-11-29
• Last updated: 2021-07-07
• Results posted: 2021-07-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study