Clinical Accuracy of the welloStationX

• Sponsor: Wello Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03758157
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Actual Duration (Months): 1
• Patients Per Site Per Month: 108

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fever	Diagnostic Test: welloStationX; Diagnostic Test: SureTemp

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 110 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: welloStationX Determination of Clinical Accuracy
• Actual Study Start Date: Oct 15, 2018
• Actual Primary Completion Date: Nov 15, 2018
• Actual Study Completion Date: Nov 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
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; 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.

Outcome Measures

Primary Outcome Measures

1. Clinical Agreement Through Clinical Bias Evaluation [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 Outcome Measures

1. Clinical Repeatability [one day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Agape Clinic	Dallas	Texas	United States	75246

Sponsors and Collaborators

• Wello Inc.

Investigators

• Study Chair: Alan C Heller, Wello Inc.

Study Documents (Full-Text)

• Study Protocol - Sep 21, 2018
• Statistical Analysis Plan - Nov 28, 2018

More Information

Publications

None provided.

• Responsible Party: Wello Inc.
• ClinicalTrials.gov Identifier: NCT03758157
• Other Study ID Numbers: Wello_X
• First Posted: Nov 29, 2018
• Last Update Posted: Jul 7, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	welloStationX Automated Non-Contact Thermometer
Arm/Group Description	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.
Period Title: Overall Study
STARTED	110
COMPLETED	110
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Temperature Measurement
Arm/Group Description	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.
Overall Participants	110
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.78 (16.14)
Sex: Female, Male (Count of Participants)
Female	74 67.3%
Male	36 32.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	54 49.1%
Not Hispanic or Latino	56 50.9%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	110 100%
febrility (Count of Participants)
febrile subjects (temperature >=99.5 deg. C)	33 30%
afebrile subjects (temperature < 99.5 deg. C)	77 70%

Outcome Measures

1. Primary Outcome

Title	Clinical Agreement Through Clinical Bias Evaluation
Description	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.
Time Frame	one day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Temperature Measurement
Arm/Group 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.
Measure Participants	110
Mean (Standard Deviation) [degrees Farehheit]	0.04 (0.42)

2. Secondary Outcome

Title	Clinical Repeatability
Description	Clinical Repeatability was calculated using the pooled standard deviations of the triplicate measurements recorded by the welloStationX.
Time Frame	one day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Temperature Measurement
Arm/Group 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.
Measure Participants	110
Number [degrees Farehheit]	0.062

Adverse Events

Time Frame	One day.
Arm/Group Title	Temperature Measurement
Arm/Group 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. 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.
All Cause Mortality
	Temperature Measurement
	Affected / at Risk (%)	# Events
Total	0/110 (0%)
Serious Adverse Events
	Temperature Measurement
	Affected / at Risk (%)	# Events
Total	0/110 (0%)
Other (Not Including Serious) Adverse Events
	Temperature Measurement
	Affected / at Risk (%)	# Events
Total	0/110 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.