FebrileNCT06353490
The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers
A study testing Infrared Forehead Thermometer (GE-TF03), Infrared Ear Thermometer (GE-TE06) and Electronic Thermometer (MT-B321FB) in people with Febrile and Healthy, run by Geon Corporation at 2 sites in Taiwan.
Trial summary
Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices. Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- What is being tested?
- Infrared Forehead Thermometer (GE-TF03), Infrared Ear Thermometer (GE-TE06) and Electronic Thermometer (MT-B321FB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesTaiwan
- Study dates
- 12 Aug 2022to 11 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Newborn to 80 years old adult
- Male or Female
- The subject or parent/guardian can talk to the researcher, understand the content of the study after researcher's explanation and agree to sign the subject's consent form, and is willing to accept the trial procedure.
Who cannot join
- Currently have signs or symptoms of infection or inflammation at the temperature measurement site (axillary, forehead, ear canal)
- The forehead cannot be fully exposed to the environment for more than 15 minutes
- Using cooling blankets, fans, or placing ice cubes on the forehead
- There is a catheter placed in the ear
- Use of antipyretics (such as aspirin, ibuprofen), barbiturates, antipsychotics in the past 2 hours
- Received thyroxine, corticosteroids or immunotherapy in the past 7 days
Show all 11Show fewer
- Subject has been diagnosed with cognitive impairment or has a history of dementia, mental illness, mental illness, pervasive developmental disorder, illicit drug use or alcoholism, etc.
- Pregnant women
- The researcher considers that the subject is not suitable for participating in this trial, such as taking any drugs that may change body temperature
- Participated in clinical trials of investigational drugs within the last 30 days
- The subject is unwilling to sign the subject's consent form
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Hsinchu MacKay Memorial Hospital
Hsinchu
HsinChu Municipal MacKay Memorial Hospital
Hsinchu
About this study
Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices.
The main objectives of this study are:
- To verify that the investigational devices and the reference medical devices have a reasonable deviation value.
- To verify the consistency of repeated measurements of investigational devices.
Read the detailed description
This Study carried out in accordance with the ISO 80601-2-56: 2017, which included definitions for the age groups and sample sizes, the definition of fever, the flowchart for relevant procedures, and statistical methods for clinical performance.
All subjects were measured by the reference device (electronic thermometer MT-B231) and three investigational devices under test evaluation (infrared forehead thermometer GE-TF03, infrared ear thermometer GE-TE06, and electronic thermometer MT-B321FB). For each subject, the reference device measured one time and each investigational device measured three times respectively.
- Being tested
- Infrared Forehead Thermometer (GE-TF03), Infrared Ear Thermometer (GE-TE06), Electronic Thermometer (MT-B321FB), Electronic Thermometer (MT-B231)
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared Forehead Thermometer (GE-TF03)Device
Infrared Forehead Thermometer (GE-TF03) is an investigational device intended to measure body temperature on the forehead. GE-TF03 took three measurements for each subject.
Infrared Ear Thermometer (GE-TE06)Device
Infrared Ear Thermometer (GE-TE06) is an investigational device intended to measure body temperature in the ear canal. GE-TF06 took three measurements for each subject.
Electronic Thermometer (MT-B321FB)Device
Electronic Thermometer (MT-B321FB) is an investigational device intended to measure body temperature on the temporal artery. MT-B321FB took three measurements for each subject.
Electronic Thermometer (MT-B231)Device
Electronic Thermometer (MT-B231) is a reference device that measured axillary temperature one time for each subject.
| Study group | Role | What they receive |
|---|---|---|
| Subjects: 0 up to 1 year | Other | Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer Receives: Device: Infrared Forehead Thermometer (GE-TF03); Device: Infrared Ear Thermometer (GE-TE06); Device: Electronic Thermometer (MT-B321FB); Device: Electronic Thermometer (MT-B231) |
| Subjects: Older than 1 year and younger than 5 years | Other | Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer Receives: Device: Infrared Forehead Thermometer (GE-TF03); Device: Infrared Ear Thermometer (GE-TE06); Device: Electronic Thermometer (MT-B321FB); Device: Electronic Thermometer (MT-B231) |
| Subjects: Older than 5 years | Other | Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer Receives: Device: Infrared Forehead Thermometer (GE-TF03); Device: Infrared Ear Thermometer (GE-TE06); Device: Electronic Thermometer (MT-B321FB); Device: Electronic Thermometer (MT-B231) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Bias
Mean Difference between investigational thermometer and reference thermometer.
Measured: Through study completion, an average of 2 years
Limits of Agreement
The magnitude of a potential disagreement between investigational thermometer and reference thermometer.
Measured: Through study completion, an average of 2 years
Clinical Repeatability
Pooled standard deviation of triplicate measurements over the entire population of subject
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start12 Aug 2022
- Primary completion8 Nov 2023
- Study completion11 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FebrileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geon Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei-Te Lei, Principal investigator, Hsinchu MacKay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353490
- Sponsor's protocol ID
- Geon-111001
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers
- ClinicalTrials.gov ID
- NCT06353490
- Acronym / sponsor ID
- Geon-111001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Geon CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 11 Aug 2024 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices.
The main objectives of this study are:
- To verify that the investigational devices and the reference medical devices have a reasonable deviation value.
- To verify the consistency of repeated measurements of investigational devices.
Detailed description
This Study carried out in accordance with the ISO 80601-2-56: 2017, which included definitions for the age groups and sample sizes, the definition of fever, the flowchart for relevant procedures, and statistical methods for clinical performance.
All subjects were measured by the reference device (electronic thermometer MT-B231) and three investigational devices under test evaluation (infrared forehead thermometer GE-TF03, infrared ear thermometer GE-TE06, and electronic thermometer MT-B321FB). For each subject, the reference device measured one time and each investigational device measured three times respectively.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects: 0 up to 1 year | Other | Device: Infrared Forehead Thermometer (GE-TF03), Device: Infrared Ear Thermometer (GE-TE06), Device: Electronic Thermometer (MT-B321FB), Device: Electronic Thermometer (MT-B231)Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer |
| Subjects: Older than 1 year and younger than 5 years | Other | Device: Infrared Forehead Thermometer (GE-TF03), Device: Infrared Ear Thermometer (GE-TE06), Device: Electronic Thermometer (MT-B321FB), Device: Electronic Thermometer (MT-B231)Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer |
| Subjects: Older than 5 years | Other | Device: Infrared Forehead Thermometer (GE-TF03), Device: Infrared Ear Thermometer (GE-TE06), Device: Electronic Thermometer (MT-B321FB), Device: Electronic Thermometer (MT-B231)Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Newborn to 80 years old adult
- Male or Female
- The subject or parent/guardian can talk to the researcher, understand the content of the study after researcher's explanation and agree to sign the subject's consent form, and is willing to accept the trial procedure.
Key exclusion criteria (11 listed)
- Currently have signs or symptoms of infection or inflammation at the temperature measurement site (axillary, forehead, ear canal)
- The forehead cannot be fully exposed to the environment for more than 15 minutes
- Using cooling blankets, fans, or placing ice cubes on the forehead
- There is a catheter placed in the ear
- Use of antipyretics (such as aspirin, ibuprofen), barbiturates, antipsychotics in the past 2 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared Forehead Thermometer (GE-TF03)Infrared Forehead Thermometer (GE-TF03) is an investigational device intended to measure body temperature on the forehead. GE-TF03 took three measurements for each subject. | Device | Subjects: 0 up to 1 year, Subjects: Older than 1 year and younger than 5 years, Subjects: Older than 5 years |
| Infrared Ear Thermometer (GE-TE06)Infrared Ear Thermometer (GE-TE06) is an investigational device intended to measure body temperature in the ear canal. GE-TF06 took three measurements for each subject. | Device | Subjects: 0 up to 1 year, Subjects: Older than 1 year and younger than 5 years, Subjects: Older than 5 years |
| Electronic Thermometer (MT-B321FB)Electronic Thermometer (MT-B321FB) is an investigational device intended to measure body temperature on the temporal artery. MT-B321FB took three measurements for each subject. | Device | Subjects: 0 up to 1 year, Subjects: Older than 1 year and younger than 5 years, Subjects: Older than 5 years |
| Electronic Thermometer (MT-B231)Electronic Thermometer (MT-B231) is a reference device that measured axillary temperature one time for each subject. | Device | Subjects: 0 up to 1 year, Subjects: Older than 1 year and younger than 5 years, Subjects: Older than 5 years |
Primary outcome
Clinical Bias
Time frame: Through study completion, an average of 2 years
Mean Difference between investigational thermometer and reference thermometer.
Limits of Agreement
Time frame: Through study completion, an average of 2 years
The magnitude of a potential disagreement between investigational thermometer and reference thermometer.
Clinical Repeatability
Time frame: Through study completion, an average of 2 years
Pooled standard deviation of triplicate measurements over the entire population of subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
Related trials for Febrile
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Te Lei principal investigator
Hsinchu MacKay Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared Forehead Thermometer (GE-TF03), Infrared Ear Thermometer (GE-TE06) and Electronic Thermometer (MT-B321FB) in people with Febrile and Healthy, run by Geon Corporation at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Bias (time frame: Through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.