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The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers

NCT06353490 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-04-09

No results posted yet for this study

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.

Conditions

  • Febrile
  • Healthy

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.

Sponsors & Collaborators

  • Geon Corporation

    lead INDUSTRY

Principal Investigators

  • Wei-Te Lei · Hsinchu MacKay Memorial Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-12
Primary Completion
2023-11-08
Completion
2024-08-11

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06353490 on ClinicalTrials.gov