The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers

Not Applicable

Active, not recruiting

• Conditions: Febrile; Healthy

• Registration Number: NCT06353490
• Lead Sponsor: Geon Corporation

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.

Study Timeline

• Study Start: 2022-08-12
• Primary Completion: 2023-11-08
• Study First Submitted: 2024-03-20
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Study Completion: 2024-08-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Limits of Agreement	Through study completion, an average of 2 years	The magnitude of a potential disagreement between investigational thermometer and reference thermometer.
Clinical Bias	Through study completion, an average of 2 years	Mean Difference between investigational thermometer and reference thermometer.
Clinical Repeatability	Through study completion, an average of 2 years	Pooled standard deviation of triplicate measurements over the entire population of subject

Trial Locations

Locations (2)

Hsinchu MacKay Memorial Hospital; 🇨🇳 Hsinchu, Taiwan

HsinChu Municipal MacKay Memorial Hospital; 🇨🇳 Hsinchu, Taiwan