Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06353490
NA

The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers

Sponsor: Geon Corporation

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2022-08-12

Completion Date

2024-08-11

Last Updated

2024-04-09

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (2)

Hsinchu MacKay Memorial Hospital

Hsinchu, Taiwan

HsinChu Municipal MacKay Memorial Hospital

Hsinchu, Taiwan