Clinical Accuracy of the welloStationX

Fever Clinical Trial

Official title:

welloStationX Determination of Clinical Accuracy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758157
• Other study ID #: Wello_X
• Status: Completed
• Start date: October 15, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: June 2021
• Source: Wello Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Male or female.

• 5 years and up.

• Signed informed consent form.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fever

Intervention

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.
• SureTemp
SureTemp is an oral thermometer to measure human body skin temperature.

Locations

Country	Name	City	State
United States	Agape Clinic	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Wello Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	one day
Secondary	Clinical Repeatability	Clinical Repeatability was calculated using the pooled standard deviations of the triplicate measurements recorded by the welloStationX.	one day