The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers

NCT06353490 | Active Not Recruiting

• 1 other identifier: Geon-111001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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. 1.To verify that the investigational devices and the reference medical devices have a reasonable deviation value.
2. 2.To verify the consistency of repeated measurements of investigational devices.

Conditions

Febrile; Healthy

Outcome Measures

Primary Outcomes (3)

• Clinical Bias

  Mean Difference between investigational thermometer and reference thermometer.

  Through study completion, an average of 2 years

• Limits of Agreement

  The magnitude of a potential disagreement between investigational thermometer and reference thermometer.

  Through study completion, an average of 2 years

• Clinical Repeatability

  Pooled standard deviation of triplicate measurements over the entire population of subject

  Through study completion, an average of 2 years

Study Arms (3)

Subjects: 0 up to 1 year

OTHER

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

Device: Infrared Forehead Thermometer (GE-TF03); Device: Infrared Ear Thermometer (GE-TE06); Device: Electronic Thermometer (MT-B321FB); Device: Electronic Thermometer (MT-B231)

Subjects: Older than 1 year and younger than 5 years

OTHER

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

Device: Infrared Forehead Thermometer (GE-TF03); Device: Infrared Ear Thermometer (GE-TE06); Device: Electronic Thermometer (MT-B321FB); Device: Electronic Thermometer (MT-B231)

Subjects: Older than 5 years

OTHER

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

Device: Infrared Forehead Thermometer (GE-TF03); Device: Infrared Ear Thermometer (GE-TE06); Device: Electronic Thermometer (MT-B321FB); Device: Electronic Thermometer (MT-B231)

Interventions

Infrared Forehead Thermometer (GE-TF03) 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.

Subjects: 0 up to 1 year; Subjects: Older than 1 year and younger than 5 years; Subjects: Older than 5 years

Infrared Ear Thermometer (GE-TE06) 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.

Subjects: 0 up to 1 year; Subjects: Older than 1 year and younger than 5 years; Subjects: Older than 5 years

Electronic Thermometer (MT-B321FB) 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.

Subjects: 0 up to 1 year; Subjects: Older than 1 year and younger than 5 years; Subjects: Older than 5 years

Electronic Thermometer (MT-B231) DEVICE

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

Subjects: 0 up to 1 year; Subjects: Older than 1 year and younger than 5 years; Subjects: Older than 5 years

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Geon Corporation: lead

Study Sites (2)

Hsinchu MacKay Memorial Hospital

Hsinchu, Taiwan

Location

HsinChu Municipal MacKay Memorial Hospital

Hsinchu, Taiwan

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei-Te Lei

  Hsinchu MacKay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 9, 2024
• Study Start: August 12, 2022
• Primary Completion: November 8, 2023
• Study Completion: August 11, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

TW (2)