HealthyNCT05640310
Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature
An observational study of Healthy and Febrile Illness, run by Norbert Health.
Trial summary
The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Febrile Illness
- What is being tested?
- Norbert Device
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Jul 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be conducted within an Emergency Department where each subject is assigned an Emergency Severity Index (ESI) score. Only subjects with ESI scores ranging from 3-5 will be recruited for the study to prevent intervening with standard patient care.
Who may be able to join
- Male or female subjects over 22 years of age
- Ability to provide signed informed consent, and/or have a legally authorized representative (LAR) willing to provide informed consent on behalf of the subject
- ESI score of 3-5
Who cannot join
- Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the study procedure
- Recent immunization within seven days of the study procedure
- Pregnancy
- ESI score of 1-2
About this study
The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).
Read the detailed description
The study design is based on the ISO 80601-2-56, Clause 201.102 for adjusted mode clinical thermometers. The study is designed to be a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's temperature measurement compared to a standard FDA 510(k)-cleared reference clinical thermometer (RCT).
- Conditions
- Healthy, Febrile Illness
- Being tested
- Norbert Device
- Keywords
- medical device, validation, febrile, thermometer, body temperature, Norbert Device, Norbert Health
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norbert DeviceDevice
The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Bias
Clinical Bias will be evaluated by comparing the first recorded measurement using ND with the corresponding measurement recorded by the RCT. The bias is calculated per IEC 80601-2-56, Clause 201.103.3.
Measured: Up to 1 hour
Limits of Agreement
Limits of Agreement (LOA) will be calculated using all three measurements by the ND and the corresponding measurements by the RCT. The LOA is calculated per IEC 80601-2-56, Clause 201.103.4.
Measured: Up to 1 hour
Clinical Repeatability
Clinical Repeatability is calculated by a pooled standard deviation of the triplicate measurements over the entire population of subjects. The method to calculate Clinical Repeatability is per IEC 80601-2-56, Clause 201.102.5.
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 posted7 Dec 2022
- Study startMar 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Internal decision made by Norbert Health
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norbert Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwell Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640310
- Sponsor's protocol ID
- NCP-0001
- Status last verified
- Aug 2023
- First submitted
- 28 Nov 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature
- ClinicalTrials.gov ID
- NCT05640310
- Acronym / sponsor ID
- NCP-0001
- Conditions
- Healthy, Febrile Illness
- Keywords
- medical device, validation, febrile, thermometer, body temperature, Norbert Device, Norbert Health
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Internal decision made by Norbert Health
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norbert HealthIndustry (pharma, biotech, devices)
- Collaborators
- Northwell Health
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 7 Dec 2022 (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 study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).
Detailed description
The study design is based on the ISO 80601-2-56, Clause 201.102 for adjusted mode clinical thermometers. The study is designed to be a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's temperature measurement compared to a standard FDA 510(k)-cleared reference clinical thermometer (RCT).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted within an Emergency Department where each subject is assigned an Emergency Severity Index (ESI) score. Only subjects with ESI scores ranging from 3-5 will be recruited for the study to prevent intervening with standard patient care.
Key inclusion criteria (3 listed)
- Male or female subjects over 22 years of age
- Ability to provide signed informed consent, and/or have a legally authorized representative (LAR) willing to provide informed consent on behalf of the subject
- ESI score of 3-5
Key exclusion criteria (4 listed)
- Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the study procedure
- Recent immunization within seven days of the study procedure
- Pregnancy
- ESI score of 1-2
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 |
|---|---|---|
| Norbert DeviceThe Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate. | Device | – |
Primary outcome
Clinical Bias
Time frame: Up to 1 hour
Clinical Bias will be evaluated by comparing the first recorded measurement using ND with the corresponding measurement recorded by the RCT. The bias is calculated per IEC 80601-2-56, Clause 201.103.3.
Limits of Agreement
Time frame: Up to 1 hour
Limits of Agreement (LOA) will be calculated using all three measurements by the ND and the corresponding measurements by the RCT. The LOA is calculated per IEC 80601-2-56, Clause 201.103.4.
Clinical Repeatability
Time frame: Up to 1 hour
Clinical Repeatability is calculated by a pooled standard deviation of the triplicate measurements over the entire population of subjects. The method to calculate Clinical Repeatability is per IEC 80601-2-56, Clause 201.102.5.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Febrile Illness, run by Norbert Health.
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 4 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: withdrawn, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 24 Aug 2023.