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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05014152
• Other study ID #: QOCA-01
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: September 23, 2022

Study information

• Verified date: July 2022
• Source: Chang Gung Memorial Hospital
• Contact: Wo-Yun Lee, Masters
• Phone: +886975056142
• Email: ginnylee6174[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 133
• Est. completion date: September 23, 2022
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 100 Years

Eligibility

Inclusion Criteria:

• 1. Male or female aged between 0-100 years.

• 2. Patient agrees to participate in the trial and sign informed consent.

Exclusion Criteria:

• 1. Those who have any broken skin or skin diseases on the part of the body which is the test site of the BLE thermometer, Including the underarms and the back of the body.

• 2. Those whose test site of the BLE thermometer are known to be contaminated by uncle arable body fluids, or lead to the inaccurate of the BLE thermometer.

• 3. Those who have restlessness or other conditions that make them unable to tolerate the temperature measurement procedure.

Related Conditions & MeSH terms

• Fever

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	ChangGungMH	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Quanta Computer Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical bias	Use the first value of the 3 test patch body temperature data to calculate and analyze the paired data of the test subject with the reference body temperature data.	10 min
Secondary	Safety /Adverse Event Outcome Measure	Number of Participants with Serious and Non-Serious Adverse Events	20 min / 24 hour (until recovered if it's SAE)