Clinical Accuracy of the welloStationX

NCT03758157 | Completed Results FDA Device

• 1 other identifier: Wello_X
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Repeatability

  one day

Study Arms (1)

Temperature Measurement

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

Diagnostic Test: welloStationX; Diagnostic Test: SureTemp

Interventions

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.

Temperature Measurement

SureTemp DIAGNOSTIC_TEST

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

Temperature Measurement

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be selected from amongst non-profit clinical sites and through social media posts for subjects to come to a test site or to be evaluated in his or her own home in the widespread Dallas/Fort Worth area.

You may qualify if:

• Male or female.
• years and up.
• Signed informed consent form.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wello Inc.: lead

Study Sites (1)

Agape Clinic

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Alan C. Heller
• Organization: Wello, Inc.

allen.heller@welloinc.com

469-522-5200

Study Officials

• Alan C Heller

  Wello Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: October 15, 2018
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: July 7, 2021
• Results First Posted: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)