Febrile IllnessNCT05721131
NC Thermometer (Gen 3) ISO 80601-2-56 Validation
An observational study of Febrile Illness and Healthy, run by Natural Cycles at 2 sites in United States.
Trial summary
The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a reference clinical thermometer. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Febrile Illness, Healthy, Fever
- What is being tested?
- NC° Thermometer (Gen 3)
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2023to 27 Apr 2023
- Phase
- Observational
- 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 5 years and older
- All sexes
- Child, Adult, Older adult
Study population: Subjects will be asked to participate and enrolled during standard visits to the medical clinic or office location.
Who may be able to join
- They are more than 5 years old
- They have not taken any antipyretic in the preceding 120 minutes
- They have no medical conditions which might impact the clinical accuracy validation results, such as inflammation at the measuring site (the mouth)
- They are not taking medications such as barbiturates, thyroid preparations, antipsychotics, and recent immunizations
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Choice Health Network- Reyes Health Center
Anaheim, California, 92804
Natural Cycles
New York, New York, 10036
About this study
The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a reference clinical thermometer.
Read the detailed description
The purpose of this clinical study is to validate the clinical accuracy of the NC° Thermometer (Gen 3) according to the requirements of ISO 80601-2-56:2017. The NC° Thermometer (Gen 3) (the device under study (DUT)) is a predictive thermometer that operates in adjusted mode. The Welch Allyn oral thermometer (Welch Allyn Spot Vital Signs 420 SureTemp temperature module, Welch Allyn, San Diego, CA) with a measurement accuracy of ± 0.1 °C in monitor mode will be used the reference clinical thermometer (RCT). During the clinical study, subjects will be asked to perform three consecutive oral measurements with the DUT, and one oral measurement with the RCT.
- Conditions
- Febrile Illness, Healthy, Fever
- Being tested
- NC° Thermometer (Gen 3)
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC° Thermometer (Gen 3)Device
The NC° Thermometer (Gen3) is used orally for the intermittent measurement and monitoring of human body temperature. The device can be used by adults and children over the age of 5 years old.
| Study group | Role | What they receive |
|---|---|---|
| Temperature measurement | Each subject will have their temperature measured by both the NC° Thermometer (Gen 3) and the reference clinical thermometer. Receives: Device: NC° Thermometer (Gen 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Bias
Clinical bias is the mean difference between the output temperatures of the NC° Thermometer (Gen 3) (DUT) and the reference clinical thermometer (RCT) for a specific reference body site (the mouth) when measured from a selected group of subjects. The clinical bias of the DUT defines closeness between the DUT output temperature and that of the RCT.
Measured: Up to 1 hour
Limits of agreement
Dispersion of output temperatures around the clinical bias can be estimated by the standard deviation of the temperature differences between the DUT and the RCT as measured from multiple subjects.
Measured: Up to 1 hour
Clinical repeatability
Clinical repeatability (sometimes called the perceived accuracy) is a measure of the consistency of repeated measurements with identical operating conditions when temperatures are taken within short time intervals from the same measuring site of the same subject by the same operator with the same intermittent clinical thermometer. Clinical repeatability is a pooled standard deviation of triplicate measurements over the population of subjects.
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start10 Jan 2023
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile IllnessStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Cycles
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721131
- Sponsor's protocol ID
- 2023001
- Status last verified
- Oct 2023
- First submitted
- 31 Jan 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NC Thermometer (Gen 3) ISO 80601-2-56 Validation
- ClinicalTrials.gov ID
- NCT05721131
- Acronym / sponsor ID
- 2023001
- Conditions
- Febrile Illness, Healthy, Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Natural CyclesIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 9 Feb 2023 (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.
The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a reference clinical thermometer.
Detailed description
The purpose of this clinical study is to validate the clinical accuracy of the NC° Thermometer (Gen 3) according to the requirements of ISO 80601-2-56:2017. The NC° Thermometer (Gen 3) (the device under study (DUT)) is a predictive thermometer that operates in adjusted mode. The Welch Allyn oral thermometer (Welch Allyn Spot Vital Signs 420 SureTemp temperature module, Welch Allyn, San Diego, CA) with a measurement accuracy of ± 0.1 °C in monitor mode will be used the reference clinical thermometer (RCT). During the clinical study, subjects will be asked to perform three consecutive oral measurements with the DUT, and one oral measurement with the RCT.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temperature measurement | – | Device: NC° Thermometer (Gen 3)Each subject will have their temperature measured by both the NC° Thermometer (Gen 3) and the reference clinical thermometer. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be asked to participate and enrolled during standard visits to the medical clinic or office location.
Key inclusion criteria (4 listed)
- They are more than 5 years old
- They have not taken any antipyretic in the preceding 120 minutes
- They have no medical conditions which might impact the clinical accuracy validation results, such as inflammation at the measuring site (the mouth)
- They are not taking medications such as barbiturates, thyroid preparations, antipsychotics, and recent immunizations
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NC° Thermometer (Gen 3)The NC° Thermometer (Gen3) is used orally for the intermittent measurement and monitoring of human body temperature. The device can be used by adults and children over the age of 5 years old. | Device | Temperature measurement |
Primary outcome
Clinical Bias
Time frame: Up to 1 hour
Clinical bias is the mean difference between the output temperatures of the NC° Thermometer (Gen 3) (DUT) and the reference clinical thermometer (RCT) for a specific reference body site (the mouth) when measured from a selected group of subjects. The clinical bias of the DUT defines closeness between the DUT output temperature and that of the RCT.
Limits of agreement
Time frame: Up to 1 hour
Dispersion of output temperatures around the clinical bias can be estimated by the standard deviation of the temperature differences between the DUT and the RCT as measured from multiple subjects.
Clinical repeatability
Time frame: Up to 1 hour
Clinical repeatability (sometimes called the perceived accuracy) is a measure of the consistency of repeated measurements with identical operating conditions when temperatures are taken within short time intervals from the same measuring site of the same subject by the same operator with the same intermittent clinical thermometer. Clinical repeatability is a pooled standard deviation of triplicate measurements over the population of subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Illness and Healthy, run by Natural Cycles at 2 sites in United States.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 30 Oct 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Up to 1 hour). 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 30 Oct 2023.