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Prospective Trial for Clinical Validation of "QOCA Disposable BLE Thermometer "

Fever Clinical Trial

Official title:
Prospective Trial for Clinical Validation of "QOCA Disposable BLE Thermometer "

Clinical Trial Summary

The purpose of this trial is to evaluate the accuracy and safety of the "QOCA Disposable Body Temperature Patch" (Q-temp-w1).

Clinical Trial Description

Q-temp-w1 is a contact type body temperature patch developed by Quanta Computer Co., Ltd. It is mainly used to measure the body temperature of the human body. It can be used for general body temperature measurement, home temperature measurement records and medical tracking. Both the European Union and the US FDA state that the clinical test methods of the temperature patch must comply with ISO 80601-2-56. Therefore, this test plan will follow the ISO 80601-2-56 criteria to evaluate the accuracy of the temperature patch and follow it. The sampling age range and the fever/non-fever ratio are stratified, and clinical efficacy analysis is performed based on the measurement results. The main evaluation indicators include clinical bias, limits of agreement, and clinical repeatability. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05014152
Study type Interventional
Source Chang Gung Memorial Hospital
Contact Wo-Yun Lee, Masters
Phone +886975056142
Email ginnylee6174@gmail.com
Status Recruiting
Phase N/A
Start date March 24, 2021
Completion date September 23, 2022
View Details
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