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

Not Applicable

Completed

• Conditions: Fever
• Interventions: Device: Q-temp-w1; Device: Omron thermometer(MC-171W)

• Registration Number: NCT05014152
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Study Timeline

• Study Start: 2021-03-24
• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-20
• Primary Completion: 2022-09-23
• Study Completion: 2022-09-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single group	Omron thermometer(MC-171W)	This study is specially designed according to its age range and customized/non-customized range, and meets the requirements of ISO 80601-2-56 test population (table). Comply with the age range and population requirements of ISO 80601-2-56, as well as clinical and subject trials, including news to the population over five years old, and hopefuls must account for at least 30% of the total and less than 50% of the total. Each subject uses Q-temp-w1 to measure axillary temperature and obtains 3 temperature values, and at the same time uses a reference body temperature patch (Omron thermometer MC-171W) to measure the other side axillary temperature, and 1 is measured Temperature value data. Perform clinical efficacy analysis based on the measurement results. The main evaluation indicators of the trial include clinical bias, limits of agreement, and clinical repeatability.
Single group	Q-temp-w1	This study is specially designed according to its age range and customized/non-customized range, and meets the requirements of ISO 80601-2-56 test population (table). Comply with the age range and population requirements of ISO 80601-2-56, as well as clinical and subject trials, including news to the population over five years old, and hopefuls must account for at least 30% of the total and less than 50% of the total. Each subject uses Q-temp-w1 to measure axillary temperature and obtains 3 temperature values, and at the same time uses a reference body temperature patch (Omron thermometer MC-171W) to measure the other side axillary temperature, and 1 is measured Temperature value data. Perform clinical efficacy analysis based on the measurement results. The main evaluation indicators of the trial include clinical bias, limits of agreement, and clinical repeatability.

Primary Outcome Measures

Name	Time	Method
Clinical bias	10 min	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.

Secondary Outcome Measures

Name	Time	Method
Safety /Adverse Event Outcome Measure	20 min / 24 hour (until recovered if it's SAE)	Number of Participants with Serious and Non-Serious Adverse Events

Trial Locations

Locations (1)

ChangGungMH; 🇨🇳 Taoyuan, Taiwan