The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers

Healthy Clinical Trial

Official title:

The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06353490
• Other study ID #: Geon-111001
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: August 11, 2024

Study information

• Verified date: April 2024
• Source: Geon Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices.

The main objectives of this study are:

1. To verify that the investigational devices and the reference medical devices have a reasonable deviation value.

2. To verify the consistency of repeated measurements of investigational devices.

Description:

This Study carried out in accordance with the ISO 80601-2-56: 2017, which included definitions for the age groups and sample sizes, the definition of fever, the flowchart for relevant procedures, and statistical methods for clinical performance.

All subjects were measured by the reference device (electronic thermometer MT-B231) and three investigational devices under test evaluation (infrared forehead thermometer GE-TF03, infrared ear thermometer GE-TE06, and electronic thermometer MT-B321FB). For each subject, the reference device measured one time and each investigational device measured three times respectively.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: August 11, 2024
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• Newborn to 80 years old adult

• Male or Female

• The subject or parent/guardian can talk to the researcher, understand the content of the study after researcher's explanation and agree to sign the subject's consent form, and is willing to accept the trial procedure.

Exclusion Criteria:

• Currently have signs or symptoms of infection or inflammation at the temperature measurement site (axillary, forehead, ear canal)

• The forehead cannot be fully exposed to the environment for more than 15 minutes

• Using cooling blankets, fans, or placing ice cubes on the forehead

• There is a catheter placed in the ear

• Use of antipyretics (such as aspirin, ibuprofen), barbiturates, antipsychotics in the past 2 hours

• Received thyroxine, corticosteroids or immunotherapy in the past 7 days

• Subject has been diagnosed with cognitive impairment or has a history of dementia, mental illness, mental illness, pervasive developmental disorder, illicit drug use or alcoholism, etc.

• Pregnant women

• The researcher considers that the subject is not suitable for participating in this trial, such as taking any drugs that may change body temperature

• Participated in clinical trials of investigational drugs within the last 30 days

• The subject is unwilling to sign the subject's consent form

Related Conditions & MeSH terms

• Febrile
• Healthy

Intervention

Device:
• Infrared Forehead Thermometer (GE-TF03)
Infrared Forehead Thermometer (GE-TF03) is an investigational device intended to measure body temperature on the forehead. GE-TF03 took three measurements for each subject.
• Infrared Ear Thermometer (GE-TE06)
Infrared Ear Thermometer (GE-TE06) is an investigational device intended to measure body temperature in the ear canal. GE-TF06 took three measurements for each subject.
• Electronic Thermometer (MT-B321FB)
Electronic Thermometer (MT-B321FB) is an investigational device intended to measure body temperature on the temporal artery. MT-B321FB took three measurements for each subject.
• Electronic Thermometer (MT-B231)
Electronic Thermometer (MT-B231) is a reference device that measured axillary temperature one time for each subject.

Locations

Country	Name	City	State
Taiwan	Hsinchu MacKay Memorial Hospital	Hsinchu
Taiwan	HsinChu Municipal MacKay Memorial Hospital	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
Geon Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Bias	Mean Difference between investigational thermometer and reference thermometer.	Through study completion, an average of 2 years
Primary	Limits of Agreement	The magnitude of a potential disagreement between investigational thermometer and reference thermometer.	Through study completion, an average of 2 years
Primary	Clinical Repeatability	Pooled standard deviation of triplicate measurements over the entire population of subject	Through study completion, an average of 2 years