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

NCT ID: NCT05014152

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-24
• Study Completion Date: 2022-09-23

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.

Conditions

Fever

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Q-temp-w1

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quanta Computer Inc.

UNKNOWN

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chih-Jung Chen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chin-Jung Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Medical Fundation

Locations

ChangGungMH

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

QOCA-01

Identifier Type: -

Identifier Source: org_study_id