NCT06353490

The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Geon Corporation · Industry
• Sex: All
• Age: 80 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2022-08-12
• Primary completion: 2023-11-08
• Completion: 2024-08-11
• First posted: 2024-04-09
• Last updated: 2024-04-09

Locations

2 sites across 1 country: Taiwan