The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers

NCT ID: NCT06353490

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-12
• Study Completion Date: 2024-08-11

Brief 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.

Detailed 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.

Conditions

Febrile; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Subjects: 0 up to 1 year

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

Group Type: OTHER

Infrared Forehead Thermometer (GE-TF03)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

Electronic Thermometer (MT-B231) is a reference device that measured axillary temperature one time for each subject.

Subjects: Older than 1 year and younger than 5 years

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

Group Type: OTHER

Infrared Forehead Thermometer (GE-TF03)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

Electronic Thermometer (MT-B231) is a reference device that measured axillary temperature one time for each subject.

Subjects: Older than 5 years

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

Group Type: OTHER

Infrared Forehead Thermometer (GE-TF03)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

Electronic Thermometer (MT-B231) is a reference device that measured axillary temperature one time for each subject.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Electronic Thermometer (MT-B231)

Electronic Thermometer (MT-B231) is a reference device that measured axillary temperature one time for each subject.

Intervention Type: DEVICE

Eligibility Criteria

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

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geon Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei-Te Lei

Role: PRINCIPAL_INVESTIGATOR

Hsinchu MacKay Memorial Hospital

Locations

Hsinchu MacKay Memorial Hospital

Hsinchu, , Taiwan

HsinChu Municipal MacKay Memorial Hospital

Hsinchu, , Taiwan

Countries

Taiwan

Other Identifiers

Geon-111001

Identifier Type: -

Identifier Source: org_study_id