NCT05014152

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 100 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Fever

Interventions

Type	Name	Description
DEVICE	Q-temp-w1	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.
DEVICE	Omron thermometer(MC-171W)	Omron thermometer(MC-171W) is mainly used to measure the body temperature of the human body. The reference temperature patch used in this study is the OMRON thermometer, model: MC-171W.

Timeline

• Start date: 2021-03-24
• Primary completion: 2022-09-23
• Completion: 2022-09-23
• First posted: 2021-08-20
• Last updated: 2024-08-21

Locations

1 site across 1 country: Taiwan