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Completed

NCT Number: NCT03758157

Clinical Accuracy of the welloStationX

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.

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Agape Clinic

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

welloStationX

Diagnostic Test

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

Diagnostic Test

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

Primary outcomes

  1. Clinical Agreement Through Clinical Bias Evaluation

    Time frame: 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.

Secondary outcomes

  1. Clinical Repeatability

    Time frame: one day

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

Sponsors and collaborators

Lead sponsor

Wello Inc.

Industry

Registry information

Official study title

welloStationX Determination of Clinical Accuracy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2018
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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