The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers

Geon Corporation

Status: Active, not recruiting

Conditions: Healthy; Febrile

Treatments: Device: Infrared Forehead Thermometer (GE-TF03); Device: Electronic Thermometer (MT-B321FB); Device: Infrared Ear Thermometer (GE-TE06); Device: Electronic Thermometer (MT-B231)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06353490

Geon-111001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: Under 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Subjects: 0 up to 1 year

Other group

Description:

Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer

Treatment:

Device: Infrared Ear Thermometer (GE-TE06)

Device: Infrared Forehead Thermometer (GE-TF03)

Device: Electronic Thermometer (MT-B231)

Device: Electronic Thermometer (MT-B321FB)

Subjects: Older than 1 year and younger than 5 years

Other group

Description:

Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer

Treatment:

Device: Infrared Ear Thermometer (GE-TE06)

Device: Infrared Forehead Thermometer (GE-TF03)

Device: Electronic Thermometer (MT-B231)

Device: Electronic Thermometer (MT-B321FB)

Subjects: Older than 5 years

Other group

Description:

Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer

Treatment:

Device: Infrared Ear Thermometer (GE-TE06)

Device: Infrared Forehead Thermometer (GE-TF03)

Device: Electronic Thermometer (MT-B231)

Device: Electronic Thermometer (MT-B321FB)