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Completed

NCT Number: NCT05014152

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).

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ChangGungMH

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Q-temp-w1

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)

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.

Primary outcomes

  1. Clinical bias

    Time frame: 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 outcomes

  1. Safety /Adverse Event Outcome Measure

    Time frame: 20 min / 24 hour (until recovered if it's SAE)

    Number of Participants with Serious and Non-Serious Adverse Events

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Quanta Computer Inc.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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