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

NCT05014152 | Completed

• 1 other identifier: QOCA-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety /Adverse Event Outcome Measure

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

Study Arms (1)

Single group

EXPERIMENTAL

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; Device: Omron thermometer(MC-171W)

Interventions

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.

Single group

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.

Single group

Eligibility Criteria

• Age: 1 Day - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female aged between 0-100 years.
• \. Patient agrees to participate in the trial and sign informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Quanta Computer Inc.: collaborator

Study Sites (1)

ChangGungMH

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

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

Study Officials

• Chin-Jung Chen, MD

  Chang Gung Medical Fundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: March 24, 2021
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)