HealthySPO-TOONCT05756816
SurePulse Oximeter - a Targeted Oxygenation Observation
A study testing SurePulse VSP and SurePulse VS in people with Healthy, run by Surepulse Medical Limited at 1 site in United Kingdom.
Trial summary
This clinical investigation will investigate how accurate the SurePulse VS and SurePulse VS Patch (VSP) are for measuring blood oxygen levels (oxygen saturation). If the results are accurate, the VSP will be ready to apply for regulatory approval, meaning it could then be available for use on newborn babies in the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SurePulse VSP and SurePulse VS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Apr 2023to 26 Jul 2023
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 55
- Willing and able to provide written informed consent
- Healthy adult subjects (ASA 1)
- Non-smoker
- Willing and able to comply with study procedures and duration
Who cannot join
- Smokers or individuals exposed to high levels of carbon monoxide
- Compromised circulation, injury, or physical malfunction of the sensor sites which would limit the ability to test sites needed for the study
- Female subjects that are actively trying to get pregnant or are pregnant (confirmed by Health Assessment Form). N.B. All female participants will be offered a pregnancy test
- Unwillingness or inability to remove coloured nail polish from test digits (relevant for reference pulse oximeter) or to have medical monitoring attached
- Known health conditions disclosed on Health Assessment Form which mean that participant is not healthy
- Allergy to lidocaine
- Allergy to adhesives used in medical dressings or tapes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust
Birmingham
About this study
Official title: SurePulse Oximeter - a Targeted Oxygenation Observation: A Controlled Desaturation Study to Establish the Accuracy and Precision of the SurePulse VS Patch Newborn Vital Sign Monitor (VSP)
This clinical investigation will investigate how accurate the SurePulse VS and SurePulse VS Patch (VSP) are for measuring blood oxygen levels (oxygen saturation). If the results are accurate, the VSP will be ready to apply for regulatory approval, meaning it could then be available for use on newborn babies in the National Health Service (NHS).
Read the detailed description
Healthy volunteers who express an interest in the study and meet the eligibility criteria will be invited to participate in the study. This study will investigate the accuracy and safety of the SurePulse VS and SurePulse VS Patch (VSP) in measuring blood oxygen levels. This is done by measuring blood oxygen levels across a range of values in healthy adults. The measurements from the VS and VSP will be compared to the known correct value. The study follows the internationally agreed standard for pulse oximeter approval.
Agreeing participants will have their name, contact details, medical history, height, weight, date of birth, skin colour, emergency contact details and address recorded, as necessary to conduct the study. After completion of the eligibility and consent process, participants will be enrolled in the study. Healthy volunteers will have their blood oxygen levels temporarily reduced in a controlled and stepwise manner. Oxygen levels will not be low for the entire duration of the session. Oxygen levels will be reduced to a specific target for a few minutes at a time. Volunteers will have a small tube inserted into an artery (blood vessel) in their wrist; this will be used to take blood samples throughout the session. The blood samples will be taken, analysed and destroyed in the same room. The session should take approximately 1.5 - 2 hours in total.
The output from the study will be compared to the primary and secondary outcomes to evaluate the performance and safety of the device. This study is required for the SurePulse VSP to be regulatory approved, meaning it could then become available in the NHS.
- Conditions
- Healthy
- Being tested
- SurePulse VSP, SurePulse VS
- Keywords
- Hypoxia, Oxygen Saturation, Pulse Oximetry
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurePulse VSPDevice
A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VSP placed on the volunteer.
SurePulse VSDevice
A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VS placed on the volunteer.
| Study group | Role | What they receive |
|---|---|---|
| SurePulse VS and VSP devices | Experimental | All enrolled participants will undergo a controlled and stepwise reduction in oxygen blood levels, with both the SurePulse VS/SurePulse VSP placed on the volunteer. Receives: Device: SurePulse VSP; Device: SurePulse VS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the SpO2 accuracy of the SurePulse VS Patch Newborn Vital Sign Monitor (VSP) pulse oximeter in comparison to "gold-standard" measurements of blood SaO2 by a co-oximeter.
Oxygen saturation comparison of measurements taken by the SurePulse VSP (SpO2) and co-oximeter blood gas analyser (SaO2). For the statistical analysis, the Accuracy Root Mean Square (Arms) calculation is used to determine the SpO2 accuracy performance.
Measured: Through study completion, an average of 2 hours
Adverse events (AEs) attributable to the SurePulse medical devices
Incidence, severity and causality of all AEs with delineation of those that are attributable to the use of the SurePulse medical devices to be used as a measure of device safety. Safety is measured by adverse events attributable to SurePulse medical devices and will be measured by adverse event logs and reports and their associated reporting requirements.
Measured: Through study completion, an average of 2 hours
Secondary outcomes (3)
Validation of the SpO2 accuracy of the SurePulse VS Monitor (VS) in comparison to "gold-standard" measurements of blood SaO2 by a co-oximeter.
Oxygen saturation comparison of measurements taken by the SurePulse VS (SpO2) and co-oximeter blood gas analyser (SaO2). For the statistical analysis, the Accuracy Root Mean Square (Arms) calculation is used to determine the SpO2 accuracy performance.
Measured: Through study completion, an average of 2 hours
Validation of the pulse rate accuracy of the SurePulse VS Patch Newborn Vital Sign Monitor (VSP) pulse oximeter in comparison to ECG.
Pulse Rate comparison of measurements taken by the SurePulse VSP and ECG. For the statistical analysis, the Accuracy Root Mean Square (Arms) calculation is used to determine the Pulse Rate accuracy performance.
Measured: Through study completion, an average of 2 hours
Validation of the pulse rate accuracy of the SurePulse VS Monitor (VS) in comparison to ECG.
Pulse Rate comparison of measurements taken by the SurePulse VS and ECG. For the statistical analysis, the Accuracy Root Mean Square (Arms) calculation is used to determine the Pulse Rate accuracy performance.
Measured: Through study completion, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start27 Apr 2023
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A controlled and stepwise reduction in oxygen blood levels, with both the SurePulse VS and SurePulse VSP placed on the volunteer.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surepulse Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Birmingham NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Murray du Plessis, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756816
- Sponsor's protocol ID
- VSP-CI-01
- Other IDs
- MTT-ISG-INS-196, 317814
- Acronym
- SPO-TOO
- Status last verified
- Jul 2023
- First submitted
- 3 Feb 2023
- Last updated
- 1 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SurePulse Oximeter - a Targeted Oxygenation Observation: A Controlled Desaturation Study to Establish the Accuracy and Precision of the SurePulse VS Patch Newborn Vital Sign Monitor (VSP)
- ClinicalTrials.gov ID
- NCT05756816
- Acronym / sponsor ID
- SPO-TOO / VSP-CI-01
- Conditions
- Healthy
- Keywords
- Hypoxia, Oxygen Saturation, Pulse Oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Surepulse Medical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Birmingham NHS Foundation Trust
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 6 Mar 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.
This clinical investigation will investigate how accurate the SurePulse VS and SurePulse VS Patch (VSP) are for measuring blood oxygen levels (oxygen saturation). If the results are accurate, the VSP will be ready to apply for regulatory approval, meaning it could then be available for use on newborn babies in the National Health Service (NHS).
Detailed description
Healthy volunteers who express an interest in the study and meet the eligibility criteria will be invited to participate in the study. This study will investigate the accuracy and safety of the SurePulse VS and SurePulse VS Patch (VSP) in measuring blood oxygen levels. This is done by measuring blood oxygen levels across a range of values in healthy adults. The measurements from the VS and VSP will be compared to the known correct value. The study follows the internationally agreed standard for pulse oximeter approval.
Agreeing participants will have their name, contact details, medical history, height, weight, date of birth, skin colour, emergency contact details and address recorded, as necessary to conduct the study. After completion of the eligibility and consent process, participants will be enrolled in the study. Healthy volunteers will have their blood oxygen levels temporarily reduced in a controlled and stepwise manner. Oxygen levels will not be low for the entire duration of the session. Oxygen levels will be reduced to a specific target for a few minutes at a time. Volunteers will have a small tube inserted into an artery (blood vessel) in their wrist; this will be used to take blood samples throughout the session. The blood samples will be taken, analysed and destroyed in the same room. The session should take approximately 1.5 - 2 hours in total.
The output from the study will be compared to the primary and secondary outcomes to evaluate the performance and safety of the device. This study is required for the SurePulse VSP to be regulatory approved, meaning it could then become available in the NHS.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A controlled and stepwise reduction in oxygen blood levels, with both the SurePulse VS and SurePulse VSP placed on the volunteer.
| Arm | Type | Receives |
|---|---|---|
| SurePulse VS and VSP devices | Experimental | Device: SurePulse VSP, Device: SurePulse VSAll enrolled participants will undergo a controlled and stepwise reduction in oxygen blood levels, with both the SurePulse VS/SurePulse VSP placed on the volunteer. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 55
- Willing and able to provide written informed consent
- Healthy adult subjects (ASA 1)
- Non-smoker
- Willing and able to comply with study procedures and duration
Key exclusion criteria (7 listed)
- Smokers or individuals exposed to high levels of carbon monoxide
- Compromised circulation, injury, or physical malfunction of the sensor sites which would limit the ability to test sites needed for the study
- Female subjects that are actively trying to get pregnant or are pregnant (confirmed by Health Assessment Form). N.B. All female participants will be offered a pregnancy test
- Unwillingness or inability to remove coloured nail polish from test digits (relevant for reference pulse oximeter) or to have medical monitoring attached
- Known health conditions disclosed on Health Assessment Form which mean that participant is not healthy
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 |
|---|---|---|
| SurePulse VSPA controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VSP placed on the volunteer. | Device | SurePulse VS and VSP devices |
| SurePulse VSA controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VS placed on the volunteer. | Device | SurePulse VS and VSP devices |
Primary outcome
Validation of the SpO2 accuracy of the SurePulse VS Patch Newborn Vital Sign Monitor (VSP) pulse oximeter in comparison to "gold-standard" measurements of blood SaO2 by a co-oximeter.
Time frame: Through study completion, an average of 2 hours
Oxygen saturation comparison of measurements taken by the SurePulse VSP (SpO2) and co-oximeter blood gas analyser (SaO2). For the statistical analysis, the Accuracy Root Mean Square (Arms) calculation is used to determine the SpO2 accuracy performance.
Adverse events (AEs) attributable to the SurePulse medical devices
Time frame: Through study completion, an average of 2 hours
Incidence, severity and causality of all AEs with delineation of those that are attributable to the use of the SurePulse medical devices to be used as a measure of device safety. Safety is measured by adverse events attributable to SurePulse medical devices and will be measured by adverse event logs and reports and their associated reporting requirements.
3 secondary outcomes
Validation of the SpO2 accuracy of the SurePulse VS Monitor (VS) in comparison to "gold-standard" measurements of blood SaO2 by a co-oximeter.
Time frame: Through study completion, an average of 2 hours
Validation of the pulse rate accuracy of the SurePulse VS Patch Newborn Vital Sign Monitor (VSP) pulse oximeter in comparison to ECG.
Time frame: Through study completion, an average of 2 hours
Validation of the pulse rate accuracy of the SurePulse VS Monitor (VS) in comparison to ECG.
Time frame: Through study completion, an average of 2 hours
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 1 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.
Murray du Plessis principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SurePulse VSP and SurePulse VS in people with Healthy, run by Surepulse Medical Limited at 1 site in United Kingdom.
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 7 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Validation of the SpO2 accuracy of the SurePulse VS Patch Newborn Vital Sign Monitor (VSP) pulse oximeter in comparison to "gold-standard" measurements of blood SaO2 by a co-oximeter. (time frame: Through study completion, an average of 2 hours). The study lists 2 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 1 Aug 2023.