Clinical Accuracy of the welloStationX

Wello

Status: Completed

Conditions: Fever

Treatments: Diagnostic Test: welloStationX; Diagnostic Test: SureTemp

Study type: Observational

Funder types: Industry

Identifiers

NCT03758157

Wello_X

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

110 participants in 1 patient group

Temperature Measurement

Description:

Each subject will have his or her temperature measured by both the welloStationX Automated Non-Contact Thermometer and the Welch Allyn SureTemp Oral Thermometer.

Treatment:

Diagnostic Test: welloStationX

Diagnostic Test: SureTemp