HealthyEOXYNCT03614416
Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer
A study testing EOXY device, Gold standard oximeter and SaO2 sampling in people with Healthy, run by BioSerenity at 1 site in Belgium.
Trial summary
The purpose of the study is to test the performance and safety of the Bioserenity pulse oxymeter EOXY. For that, and in agreement with ISO60601-2-61 norm and FDA regulation, measures of heart rate, with a gold-standard, and SaO2 measures generated by blood samples will be compared with Sp02 and heart rate measures… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- EOXY device, Gold standard oximeter and SaO2 sampling
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Dec 2017to 6 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Healthy subject (Man/ Women) > 18 years old
- Subject signed informed consent prior to any screening procedure
- Subject in good health (COHb < 3% , MetHb < 2%, CtHb > 10mg/dL)
- Healthy adult capable of undergoing controlled hypoxemia to the level called for in the protocol with minimal medical risk
Who cannot join
- Smokers or individuals exposed to high levels of carbon monoxide that result in elevation of carboxy hemoglobin levels
- Individual subject to conditions that result in elevated levels of methemoglobin
- Subject who would be placed at undue medical risk associated with any procedure called for in the protocol
- Subject with open wounds
- Pregnant woman (negative pregnancy test needed)
- Subject allergic to silicon, polyamide and silver yarn
Show all 12Show fewer
- Subject with cardiorespiratory disorders likely to worsen with thoracic pressure applied by the textile band
- Subject with mental or motor impairment preventing him from expressing pain
- Subject with blood or skin disorder that may impacting results
- Subject with behavioral disorders, too agitated or too aggressive
- Subject with sensorial disorders, insensible to skin pain
- Subject susceptible to tension/pressure based headaches
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Université catholique louvain la neuve, centre sportif
Louvain-la-Neuve, 1348
About this study
The purpose of the study is to test the performance and safety of the Bioserenity pulse oxymeter EOXY. For that, and in agreement with ISO60601-2-61 norm and FDA regulation, measures of heart rate, with a gold-standard, and SaO2 measures generated by blood samples will be compared with Sp02 and heart rate measures that are generated by our EOXY.
Thirteen healthy subjects will participate in the study in total. Three subjects will be enrolled during a primary phase .They will participate at a secondary phase as well as ten others subjects. The purpose of the primary phase is to test the body area where the measurement can be done. The purpose of the secondary phase is to measure SpO2 and HR in desaturation conditions.
Read the detailed description
The primary objective is to evaluate and document the SpO2 accuracy of the pulse oximeter equipment, evaluating the performance of the device compared to invasive method blood sampling (SaO2) by CO-Oximeter in healthy subjects during invasive controlled desaturation study at different ranges (100 % to 70% SaO2).
Subject safety during desaturation and saturation period, will be evaluated by reviewing vital sign: heart rate (HR) continuously and blood pressure/temperature between each desaturation plateau.
There are two secondaries objectives, the measurement of the variation of the fraction of inspired oxygen (FiO2), and the validation of the algorithm for data review and analysis.
For the study primary phase, the purpose of this phase is to test the body area where the SpO2 is better detected and define 3 measurement areas. For this, three healthy volunteers will be placed in normal O2 saturation, the SpO2 will be measured using the Bioserenity oximeter (noninvasive method) and will be compared to a gold-standard oximeter CE-marked. The investigator will determine the best area in the body where the SpO2 could be taken for the following subjects.
During a second phase, the measurement of Sp02 and HR with EOXY, will be performed in O2 saturation conditions up to 100% and then in desaturation by plateau from 100 % to 70%. 3 EOXY pulse oximeter recorded the SpO2 at the same time in 3 different areas of the body. As required by the standard, Sp02 measures will be simultaneously compared to SaO2 values measured by blood sampling taken from an indwelling arterial catheter. The HR obtained with EOXY will be compared simultaneously to a gold standard oximeter CE-marked.
As the example in the standard, it was choosen to do the test on the 70-100% range, with 5 plateaus (100%-97%, 97%-92%, 92%-85%, 84%-78%, 77%-70%) and to collect five Sp02 and Sa02 values (blood samples) and five HR measures, per plateau, for each of 13 subjects.
The desaturation will be controlled thanks' the FiO2 measures, that should allow to bring subjects near target levels of desaturation plateau.
- Conditions
- Healthy
- Being tested
- EOXY device, Gold standard oximeter, SaO2 sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOXY deviceDevice
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Gold standard oximeterDevice
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
SaO2 samplingProcedure or surgery
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
| Study group | Role | What they receive |
|---|---|---|
| EOXY device and Gold standard oximter and SaO2 measures | Experimental | Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter Receives: Device: EOXY device; Device: Gold standard oximeter; Procedure: SaO2 sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position
For each desaturation plateau, SpO2 ARMS are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements
Measured: 1 day
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position
For each desaturation plateau, SpO2 ARMS (Accuracy Root-Mean Square) are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements
Measured: 1 day
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position
For each desaturation plateau, SpO2 ARMS are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements
Measured: 1 day
HR Accuracy Root-Mean Square (ARMS) at Forehead Position
For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements
Measured: 1 day
Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position
For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements
Measured: 1 day
Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position
For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start8 Dec 2017
- Primary completion15 Dec 2017
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- No randomisation. All subjects will test simultaneously the gold standard and the EOXY device
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioSerenity
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA, Université Catholique de Louvain
- Responsible party
- Sponsor
- Investigators
- marc FRANCAUX, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614416
- Sponsor's protocol ID
- BIOSERENITY_80601-2-61
- Acronym
- EOXY
- Status last verified
- Dec 2020
- First submitted
- 23 Apr 2018
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer
- ClinicalTrials.gov ID
- NCT03614416
- Acronym / sponsor ID
- EOXY / BIOSERENITY_80601-2-61
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- BioSerenityIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA, Université Catholique de Louvain
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 12 Jan 2021
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 the study is to test the performance and safety of the Bioserenity pulse oxymeter EOXY. For that, and in agreement with ISO60601-2-61 norm and FDA regulation, measures of heart rate, with a gold-standard, and SaO2 measures generated by blood samples will be compared with Sp02 and heart rate measures that are generated by our EOXY.
Thirteen healthy subjects will participate in the study in total. Three subjects will be enrolled during a primary phase .They will participate at a secondary phase as well as ten others subjects. The purpose of the primary phase is to test the body area where the measurement can be done. The purpose of the secondary phase is to measure SpO2 and HR in desaturation conditions.
Detailed description
The primary objective is to evaluate and document the SpO2 accuracy of the pulse oximeter equipment, evaluating the performance of the device compared to invasive method blood sampling (SaO2) by CO-Oximeter in healthy subjects during invasive controlled desaturation study at different ranges (100 % to 70% SaO2).
Subject safety during desaturation and saturation period, will be evaluated by reviewing vital sign: heart rate (HR) continuously and blood pressure/temperature between each desaturation plateau.
There are two secondaries objectives, the measurement of the variation of the fraction of inspired oxygen (FiO2), and the validation of the algorithm for data review and analysis.
For the study primary phase, the purpose of this phase is to test the body area where the SpO2 is better detected and define 3 measurement areas. For this, three healthy volunteers will be placed in normal O2 saturation, the SpO2 will be measured using the Bioserenity oximeter (noninvasive method) and will be compared to a gold-standard oximeter CE-marked. The investigator will determine the best area in the body where the SpO2 could be taken for the following subjects.
During a second phase, the measurement of Sp02 and HR with EOXY, will be performed in O2 saturation conditions up to 100% and then in desaturation by plateau from 100 % to 70%. 3 EOXY pulse oximeter recorded the SpO2 at the same time in 3 different areas of the body. As required by the standard, Sp02 measures will be simultaneously compared to SaO2 values measured by blood sampling taken from an indwelling arterial catheter. The HR obtained with EOXY will be compared simultaneously to a gold standard oximeter CE-marked.
As the example in the standard, it was choosen to do the test on the 70-100% range, with 5 plateaus (100%-97%, 97%-92%, 92%-85%, 84%-78%, 77%-70%) and to collect five Sp02 and Sa02 values (blood samples) and five HR measures, per plateau, for each of 13 subjects.
The desaturation will be controlled thanks' the FiO2 measures, that should allow to bring subjects near target levels of desaturation plateau.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- No randomisation. All subjects will test simultaneously the gold standard and the EOXY device
| Arm | Type | Receives |
|---|---|---|
| EOXY device and Gold standard oximter and SaO2 measures | Experimental | Device: EOXY device, Device: Gold standard oximeter, Procedure: SaO2 samplingHeart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subject (Man/ Women) > 18 years old
- Subject signed informed consent prior to any screening procedure
- Subject in good health (COHb < 3% , MetHb < 2%, CtHb > 10mg/dL)
- Healthy adult capable of undergoing controlled hypoxemia to the level called for in the protocol with minimal medical risk
Key exclusion criteria (12 listed)
- Smokers or individuals exposed to high levels of carbon monoxide that result in elevation of carboxy hemoglobin levels
- Individual subject to conditions that result in elevated levels of methemoglobin
- Subject who would be placed at undue medical risk associated with any procedure called for in the protocol
- Subject with open wounds
- Pregnant woman (negative pregnancy test needed)
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 |
|---|---|---|
| EOXY deviceSp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard | Device | EOXY device and Gold standard oximter and SaO2 measures |
| Gold standard oximeterSp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard | Device | EOXY device and Gold standard oximter and SaO2 measures |
| SaO2 samplingSp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard | Procedure or surgery | EOXY device and Gold standard oximter and SaO2 measures |
Primary outcome
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position
Time frame: 1 day
For each desaturation plateau, SpO2 ARMS are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position
Time frame: 1 day
For each desaturation plateau, SpO2 ARMS (Accuracy Root-Mean Square) are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position
Time frame: 1 day
For each desaturation plateau, SpO2 ARMS are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements
HR Accuracy Root-Mean Square (ARMS) at Forehead Position
Time frame: 1 day
For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements
Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position
Time frame: 1 day
For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements
Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position
Time frame: 1 day
For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Study of New Magnetic Resonance Imaging Methods of the Brain
Healthy Volunteer, Magnetic Resonance Imaging
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
RecruitingObservational study
Cytapheresis of Volunteer Donors
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
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.
marc FRANCAUX principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOXY device, Gold standard oximeter and SaO2 sampling in people with Healthy, run by BioSerenity at 1 site in Belgium.
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 12 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 12 Jan 2021. 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 Belgium. 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?
Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position (time frame: 1 day). The study lists 6 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 12 Jan 2021; AzTrials last refreshed its copy on 30 Oct 2026.