HealthyNCT05685654
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation
An observational study of Healthy and Hypoxia, run by Norbert Health.
Trial summary
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2 validation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Norbert Device
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 15 healthy, adult volunteers, aged 18 - 50, will be enrolled. The subjects will be distributed across both genders as equally as practical and with a range of skin pigmentation.
Who may be able to join
- Healthy, male or female subjects between the ages of 18 to 50 years
- Completion of a health screening for a medical history by a licensed physician, nurse practitioner, or physician assistant
- Previously measured hemoglobin electrophoresis with normal result recorded in Duke Epic EHR
- Minimum weight 40kg; BMI within range 18.0 - 35.0
- Assigned American Society of Anesthesiologists (ASA) Physical Status 1 by Principal Investigator or delegate
Who cannot join
- Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
- Prior known severe allergies to medical grade adhesive/tape (Band-Aid)
- Taking any medication other than birth control
- Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational interventional drug, device, or biologic study
- Has a negative Allen's Test to confirm non patency of the collateral artery
- Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure
Show all 15Show fewer
- Is female with a positive urine pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breast feeding
- Has anemia
- Has heparin allergy
- Has a history of sickle cell trait or thalassemia [self-reported]
- Has a positive urine cotinine test or urine drug screen or oral ethanol test
- Has a room air saturation less than 95% by pulse oximetry
- Has a clinically significant abnormal EKG
- Has a COHb greater than 3%, or MetHb greater than 2%
- Students and Employees under the direct supervision of PI or Sub-I
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2 validation.
Read the detailed description
The study is a single center, prospective, non-randomized study to measure the accuracy of an investigational device compared to blood reference values. The design of the study will be conducted in accordance with the recommendations of ISO 80601-2-61:2011 Annex EE.2 Procedure for invasive laboratory testing on healthy volunteers. The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the Norbert Device. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3.5 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
- Being tested
- Norbert Device
- Keywords
- medical device, validation, hypoxia, SpO2, oxygen saturation, Norbert Device, Norbert Health
- Medical subject headings
- Hypoxia
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.
SpO2 root mean square accuracy of the Norbert Device
SpO2 root mean square accuracy will be calculated following FDA guidelines.
Measured: Up to 1 hour
SpO2 bias of the Norbert Device
SpO2 bias calculation of the Norbert Device will follow the FDA guidelines for analyzing population mean bias, between-subject variance, and within-subject variance.
Measured: Up to 1 hour
Bland-Altman plots with linear regression line and 95% upper and lower limits of agreement
A method comparison study will be analyzed with a Bland-Altman plot. This study will produce limits of agreement (LoA) and associated confidence intervals from the two measurements obtained on each subject. The conclusion that the two measurements are in agreement depends on whether the confidence intervals constructed from the data are within the boundaries set from the maximum allowable difference.
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 posted17 Jan 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norbert Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685654
- Sponsor's protocol ID
- NCP-0003
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 23 Jan 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 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation
- ClinicalTrials.gov ID
- NCT05685654
- Acronym / sponsor ID
- NCP-0003
- Keywords
- medical device, validation, hypoxia, SpO2, oxygen saturation, Norbert Device, Norbert Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Norbert HealthIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 17 Jan 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 study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2 validation.
Detailed description
The study is a single center, prospective, non-randomized study to measure the accuracy of an investigational device compared to blood reference values. The design of the study will be conducted in accordance with the recommendations of ISO 80601-2-61:2011 Annex EE.2 Procedure for invasive laboratory testing on healthy volunteers. The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the Norbert Device. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3.5 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 15 healthy, adult volunteers, aged 18 - 50, will be enrolled. The subjects will be distributed across both genders as equally as practical and with a range of skin pigmentation.
Key inclusion criteria (5 listed)
- Healthy, male or female subjects between the ages of 18 to 50 years
- Completion of a health screening for a medical history by a licensed physician, nurse practitioner, or physician assistant
- Previously measured hemoglobin electrophoresis with normal result recorded in Duke Epic EHR
- Minimum weight 40kg; BMI within range 18.0 - 35.0
- Assigned American Society of Anesthesiologists (ASA) Physical Status 1 by Principal Investigator or delegate
Key exclusion criteria (15 listed)
- Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
- Prior known severe allergies to medical grade adhesive/tape (Band-Aid)
- Taking any medication other than birth control
- Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational interventional drug, device, or biologic study
- Has a negative Allen's Test to confirm non patency of the collateral artery
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
SpO2 root mean square accuracy of the Norbert Device
Time frame: Up to 1 hour
SpO2 root mean square accuracy will be calculated following FDA guidelines.
SpO2 bias of the Norbert Device
Time frame: Up to 1 hour
SpO2 bias calculation of the Norbert Device will follow the FDA guidelines for analyzing population mean bias, between-subject variance, and within-subject variance.
Bland-Altman plots with linear regression line and 95% upper and lower limits of agreement
Time frame: Up to 1 hour
A method comparison study will be analyzed with a Bland-Altman plot. This study will produce limits of agreement (LoA) and associated confidence intervals from the two measurements obtained on each subject. The conclusion that the two measurements are in agreement depends on whether the confidence intervals constructed from the data are within the boundaries set from the maximum allowable difference.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Hypoxia, 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 5 inclusion and 15 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 23 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellie Gonzalez (503-400-17222, ellie@norberthealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 root mean square accuracy of the Norbert Device (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 23 Jan 2023.