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

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

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Device: Q-temp-w1; Device: Omron thermometer(MC-171W)

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • ChangGungMH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single group; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Quanta Computer Inc.
• Investigators: Principal Investigator: Chin-Jung Chen, MD, Chang Gung Medical Fundation

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): September 23, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: QOCA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No