Oxygen DeficiencyNCT03080688
Prizma Pulse Oximeter Evaluation
An observational study of Oxygen Deficiency, run by G Medical Innovations Ltd..
Trial summary
This study is intended to evaluate performance of the new design sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically: SpO2 value range 70% to 100% 10 or more subjects, at least 3 of dark pigmentation At least 200 data points Meeting the following test required by… Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Deficiency
- What is being tested?
- Prizma Oxygen Saturation Measurement
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2016to 16 Apr 2016
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Selection of patients, both male and female, who meet the eligibility criteria (see below)
Who may be able to join
- Both male and female subjects
- Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile below.
- Meeting the demographic requirements listed above.
Who cannot join
- Smokers or individuals exposed to high levels of carbon monoxide that result in carboxyhemoglobin levels over 3% as tested by the BYL.
- Subjects who would be placed under medical risk under the desaturation profile listed below.
- Significant arrhythmia
- Age below 21 or over 50
- Pregnant women
About this study
This study is intended to evaluate performance of the new design sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically:
- SpO2 value range 70% to 100%
- 10 or more subjects, at least 3 of dark pigmentation
- At least 200 data points
- Meeting the following test required by the 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions and by ISO 80601-2-61 on Pulse Oximeters:
- 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions:
- 4.1. ACCURACY OF PULSE OXIMETERS
- 4.1.1 IN VIVO TESTING FOR SPO2 ACCURACY UNDER LABORATORY CONDITIONS
- ISO 80601-2-61:2011 Annex EE.2 and clause 201.12.1.101.2
- 201.12.1.101 SpO2 accuracy of pulse oximeter equipment
- 201.12.1.101.2 Determination of SpO2 accuracy
Read the detailed description
The device under test was the Prizma which is a phone cover biometric device that includes reflectance oximetry. This device is a spot checker that requires the patient to hold their finger on the sensor during the measurement. The subjects were asked not to move during the study. In order to get consistent measurements the fingers were taped to the test device. The tape acted mainly as a reminder, and there were some problems with finger movement. A radial arterial cannula was placed in either the left or right wrist of each subject.
Blood gas analysis to determine oxyhemoglobin saturation was performed on an OSM-3® multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen). No subject was anemic (Hemoglobin ≤ 10gm•dl-1). Each subject had control data taken at the beginning of each experiment, with two control blood samples drawn while breathing room air. Hypoxia was induced to different levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Oxyhemoglobin saturation was reduced to a series of targets and stabilized at the plateau value. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds. Two arterial blood samples were then obtained, approximately 30 seconds apart. A total of 24 samples were obtained per subject. Data were recorded by Bickler-Ye lab and provided for analysis.
- Conditions
- Oxygen Deficiency
- Being tested
- Prizma Oxygen Saturation Measurement
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prizma Oxygen Saturation MeasurementDevice
A radial arterial cannula was placed in either the left or right wrist of each subject.
Blood gas analysis to determine oxyhemoglobin saturation was performed on an OSM-3® multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen). No subject was anemic (Hemoglobin ≤ 10gm•dl-1).
| Study group | Role | What they receive |
|---|---|---|
| Prizma | Measurement of oxyhemoglobin saturation by OSM-3 oximeter and Prizma oxygen saturation measurement Receives: Device: Prizma Oxygen Saturation Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen saturation
Comparison of Measurements: Prizma Device versus Gold Standard
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start15 Apr 2016
- Primary completion15 Apr 2016
- Study completion16 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen DeficiencyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- G Medical Innovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080688
- Sponsor's protocol ID
- BYL20160415
- Status last verified
- Mar 2017
- First submitted
- 27 Feb 2017
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- 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 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prizma Pulse Oximeter Evaluation
- ClinicalTrials.gov ID
- NCT03080688
- Acronym / sponsor ID
- BYL20160415
- Conditions
- Oxygen Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- G Medical Innovations Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 15 Apr 2016 (actual)
- Study completion
- 16 Apr 2016 (actual)
- First posted
- 15 Mar 2017 (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.
This study is intended to evaluate performance of the new design sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically:
- SpO2 value range 70% to 100%
- 10 or more subjects, at least 3 of dark pigmentation
- At least 200 data points
- Meeting the following test required by the 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions and by ISO 80601-2-61 on Pulse Oximeters:
- 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions:
- 4.1. ACCURACY OF PULSE OXIMETERS
- 4.1.1 IN VIVO TESTING FOR SPO2 ACCURACY UNDER LABORATORY CONDITIONS
- ISO 80601-2-61:2011 Annex EE.2 and clause 201.12.1.101.2
- 201.12.1.101 SpO2 accuracy of pulse oximeter equipment
- 201.12.1.101.2 Determination of SpO2 accuracy
Detailed description
The device under test was the Prizma which is a phone cover biometric device that includes reflectance oximetry. This device is a spot checker that requires the patient to hold their finger on the sensor during the measurement. The subjects were asked not to move during the study. In order to get consistent measurements the fingers were taped to the test device. The tape acted mainly as a reminder, and there were some problems with finger movement. A radial arterial cannula was placed in either the left or right wrist of each subject.
Blood gas analysis to determine oxyhemoglobin saturation was performed on an OSM-3® multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen). No subject was anemic (Hemoglobin ≤ 10gm•dl-1). Each subject had control data taken at the beginning of each experiment, with two control blood samples drawn while breathing room air. Hypoxia was induced to different levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Oxyhemoglobin saturation was reduced to a series of targets and stabilized at the plateau value. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds. Two arterial blood samples were then obtained, approximately 30 seconds apart. A total of 24 samples were obtained per subject. Data were recorded by Bickler-Ye lab and provided for analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prizma | – | Device: Prizma Oxygen Saturation MeasurementMeasurement of oxyhemoglobin saturation by OSM-3 oximeter and Prizma oxygen saturation measurement |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Selection of patients, both male and female, who meet the eligibility criteria (see below)
Key inclusion criteria (3 listed)
- Both male and female subjects
- Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile below.
- Meeting the demographic requirements listed above.
Key exclusion criteria (5 listed)
- Smokers or individuals exposed to high levels of carbon monoxide that result in carboxyhemoglobin levels over 3% as tested by the BYL.
- Subjects who would be placed under medical risk under the desaturation profile listed below.
- Significant arrhythmia
- Age below 21 or over 50
- Pregnant women
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 |
|---|---|---|
| Prizma Oxygen Saturation MeasurementA radial arterial cannula was placed in either the left or right wrist of each subject. Blood gas analysis to determine oxyhemoglobin saturation was performed on an OSM-3® multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen). No subject was anemic (Hemoglobin ≤ 10gm•dl-1). | Device | Prizma |
Primary outcome
Blood oxygen saturation
Time frame: 2 days
Comparison of Measurements: Prizma Device versus Gold Standard
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 15 Mar 2017.
- 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 Oxygen Deficiency, run by G Medical Innovations Ltd..
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 5 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 15 Mar 2017. 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 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?
Blood oxygen saturation (time frame: 2 days). 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 15 Mar 2017.