Pulse OximetryNCT06912516
PULSE OXIMETRY Performance Test for a Software Medical Device 'Vitacam'
A study of Pulse Oximetry, run by Evondos Oy at 1 site in Finland.
Trial summary
This clinical investigation aims to collect data for algorithm development and testing of Vitacam as well as to later validate the system using a simultaneously collected, but segregated, hold-out validation dataset. Vitacam is a software medical device for measuring vital signs, manufactured by NE Device SW Oy. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulse Oximetry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFinland
- Study dates
- 22 Dec 2023to 1 Nov 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-40 years
- ASA category 1
- Positive Allen's test
- Passing the physical examination
- Ability to give informed consent
- Volunteering for the study
- Fluent Finnish or English
Who cannot join
- Age under 18 years or over 40 years
- Smoker
- Pregnancy
- Does not pass the physical examination
- Negative Allen's test
- Relevant medical illnesses
Show all 10Show fewer
- Cardiovascular disease
- Pulmonary disease
- Inability to give informed consent
- Denial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PULSE OXIMETRY Performance Test for Vitacam. Controlled Desaturation Test.
This clinical investigation aims to collect data for algorithm development and testing of Vitacam as well as to later validate the system using a simultaneously collected, but segregated, hold-out validation dataset. Vitacam is a software medical device for measuring vital signs, manufactured by NE Device SW Oy. It analyses digital video recorded using a smart device with a camera to locate a subject's face and chest region. From both these regions of interest, the video is further analysed to obtain the heart rate, heartbeat intervals, respiratory rate and oxygen saturation. These measurements are used as inputs to clinical decision making. Vitacam uses remote photoplethysmography to obtain the heart rate and heartbeat intervals, and will build on this to obtain oxygen saturation using information from red-green-blue channels.
The main focus of this study is to validate the oxygen saturation, heart rate and heartbeat intervals measured by Vitacam against gold standard references, applying the ISO 80601:2019 standard.
- Conditions
- Pulse Oximetry
- Being tested
- Controlled desaturation
- Keywords
- Oxygen saturation, remote photoplethysmography, pulse oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled desaturationProcedure or surgery
A subject rests comfortably on a hospital bed, so that they do not have to move during the desaturation process.
The subject wears the altitude simulator head bivy and breathes freely without any oxygen regulation. During the measurement, the time in low O2 saturation plateaus is limited to ten minutes in each desaturation plateau.
They are monitored with ECG, clinical pulse oximeter, EtCO2 from non-invasive capnography with nasal cannulas and periodically non-invasive blood pressure. The monitoring is supervised by two medical doctors, present during the entire duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Desaturation subjects | Other | This is a single arm study where healthy volunteers were subjected to a controlled desaturation protocol to ascertain if the investigational device could correctly track changes in oxygen saturation. Receives: Procedure: Controlled desaturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of oxygen saturation measurements - Root Mean Square Error
Accuracy as measured by Root Mean Square Error should be less than or equal to 4% for SpO2 as per ISO 80601-2-61:2019. It is calculated from the difference of the SpO2 measured from the investigational device and that of the reference device.
Measured: A 30-45 minute period during which the participant is subjected to the de-saturation process
Accuracy of oxygen saturation measurements - Mean absolute error
Accuracy as measured by Mean Absolute Error should be less than or equal to 4% for SpO2 as per ISO 80601-2-61:2019. It is calculated from the difference of the SpO2 measured from the investigational device and that of the reference device.
Measured: A 30-45 minute period during which the participant is subjected to the de-saturation process
Secondary outcomes (1)
Accuracy of interbeat intervals of the investigational device against successive R waves of the QRS complex from an Electrocardiogram
To validate the accuracy of Vitacam interbeat intervals, both the intervals and heart rate variability metrics derived from these intervals, will be compared to the RR intervals and heart rate variability metrics derived from a 5-lead ECG
Measured: A 30-45 minute period during which the participant is subjected to the de-saturation process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start22 Dec 2023
- Primary completion15 Sep 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse OximetryStudies 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evondos Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tampere University, Tampere University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912516
- Sponsor's protocol ID
- R23022L
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD cannot be shared due to GDPR
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PULSE OXIMETRY Performance Test for Vitacam. Controlled Desaturation Test.
- ClinicalTrials.gov ID
- NCT06912516
- Acronym / sponsor ID
- R23022L
- Conditions
- Pulse Oximetry
- Keywords
- Oxygen saturation, remote photoplethysmography, pulse oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Evondos OyIndustry (pharma, biotech, devices)
- Collaborators
- Tampere University, Tampere University Hospital
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 4 Apr 2025 (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 aims to collect data for algorithm development and testing of Vitacam as well as to later validate the system using a simultaneously collected, but segregated, hold-out validation dataset. Vitacam is a software medical device for measuring vital signs, manufactured by NE Device SW Oy. It analyses digital video recorded using a smart device with a camera to locate a subject's face and chest region. From both these regions of interest, the video is further analysed to obtain the heart rate, heartbeat intervals, respiratory rate and oxygen saturation. These measurements are used as inputs to clinical decision making. Vitacam uses remote photoplethysmography to obtain the heart rate and heartbeat intervals, and will build on this to obtain oxygen saturation using information from red-green-blue channels.
The main focus of this study is to validate the oxygen saturation, heart rate and heartbeat intervals measured by Vitacam against gold standard references, applying the ISO 80601:2019 standard.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desaturation subjects | Other | Procedure: Controlled desaturationThis is a single arm study where healthy volunteers were subjected to a controlled desaturation protocol to ascertain if the investigational device could correctly track changes in oxygen saturation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 18-40 years
- ASA category 1
- Positive Allen's test
- Passing the physical examination
- Ability to give informed consent
Key exclusion criteria (10 listed)
- Age under 18 years or over 40 years
- Smoker
- Pregnancy
- Does not pass the physical examination
- Negative Allen's test
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 |
|---|---|---|
| Controlled desaturationA subject rests comfortably on a hospital bed, so that they do not have to move during the desaturation process. The subject wears the altitude simulator head bivy and breathes freely without any oxygen regulation. During the measurement, the time in low O2 saturation plateaus is limited to ten minutes in each desaturation plateau. They are monitored with ECG, clinical pulse oximeter, EtCO2 from non-invasive capnography with nasal cannulas and periodically non-invasive blood pressure. The monitoring is supervised by two medical doctors, present during the entire duration of the study. | Procedure or surgery | Desaturation subjects |
Primary outcome
Accuracy of oxygen saturation measurements - Root Mean Square Error
Time frame: A 30-45 minute period during which the participant is subjected to the de-saturation process
Accuracy as measured by Root Mean Square Error should be less than or equal to 4% for SpO2 as per ISO 80601-2-61:2019. It is calculated from the difference of the SpO2 measured from the investigational device and that of the reference device.
Accuracy of oxygen saturation measurements - Mean absolute error
Time frame: A 30-45 minute period during which the participant is subjected to the de-saturation process
Accuracy as measured by Mean Absolute Error should be less than or equal to 4% for SpO2 as per ISO 80601-2-61:2019. It is calculated from the difference of the SpO2 measured from the investigational device and that of the reference device.
1 secondary outcome
Accuracy of interbeat intervals of the investigational device against successive R waves of the QRS complex from an Electrocardiogram
Time frame: A 30-45 minute period during which the participant is subjected to the de-saturation process
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 4 Apr 2025.
- Individual participant dataSharing planned: No. IPD cannot be shared due to GDPR
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pulse Oximetry, run by Evondos Oy at 1 site in Finland.
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 7 inclusion and 10 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 4 Apr 2025. 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 Finland. 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?
Accuracy of oxygen saturation measurements - Root Mean Square Error (time frame: A 30-45 minute period during which the participant is subjected to the de-saturation process). 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 4 Apr 2025.