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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06353490
Other study ID # Geon-111001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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