Blood Pressure MeasurementNCT07739667
Blood Pressure Measurement Using Vitacam
An observational study of Blood Pressure Measurement, run by Evondos Oy at 1 site in Finland.
Trial summary
The purpose of this clinical investigation is to collect data for the development, testing, and validation of a blood pressure measurement algorithm for a contactless vital signs monitor, Vitacam, according to the ISO 80601-2:2019 standard for validating non-invasive sphygmomanometer, with the intention of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Measurement
- What is being tested?
- rPPG blood pressure measurement medical device software
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 1 siteFinland
- Study dates
- 11 May 2026to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Residents or visitors in the Tampere Pirkanmaa region
Who may be able to join
- Age 18 years or older
- Ability to give informed consent
- Volunteering for the study
- Fluent Finnish or English
Who cannot join
- Age under 18 years
- Pregnancy
- Inability to give informed consent
- Denial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Tampere University
Tampere
Anna Karhu, MSc
About this study
The purpose of this clinical investigation is to collect data for the development, testing, and validation of a blood pressure measurement algorithm for a contactless vital signs monitor, Vitacam, according to the ISO 80601-2:2019 standard for validating non-invasive sphygmomanometer, with the intention of disseminating the validation results through a peer-reviewed scientific publication.
Read the detailed description
Vitacam is a Software-as-Medical Device (SaMD) for measuring vital physiological parameters from a video sequence from a face and chest, which uses computer vision techniques and remote photoplethysmography. This study concerns the development and validation of blood pressure measurements using Vitacam according to internationally recognised ISO (the International Organization for Standardization) standards with modifications imposed by cuffless measurements.
Based on these standards, measurements are collected simultaneously using Vitacam from facial videos, and a clinically validated auscultatory sphygmomanometer.
A minimum of 85 subjects are required for an EN ISO 81060-2:2019 + A2:2024 validation study with at least ≥30% of either sex. The SBP readings must be distributed such that ≥ 5% are ≤100 mmHG; ≥ 5% must be ≥ 160 and ≥ 20% is ≥ 140. The DBP readings must be distributed such that ≥ 5% are ≤60 mmHG; ≥ 5% must be ≥ 100 and ≥ 20% is ≥ 85. There must be at least 255 valid paired BP values.
The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019).
The standard deviation must also not exceed the value specified in Criterion 2 of the ISO standard, related to the mean difference to the reference BP.
Finally, a measuring device is considered acceptable if its estimated probability of a tolerable error (≤10mmHg) is at least 85%.
Vitacam is not intended for use in children and during pregnancy, so such subjects are excluded from the recruitment. It is intended to be used by elderly persons, so such subjects, able to give informed consent, will be recruited. As there is an increased prevalence of heart disease in the elderly, subjects diagnosed with atrial fibrillation or other irregular heart rhythms are neither excluded from the recruitment nor considered a special study population.
This study is a cross-sectional, observational, multi-site study conducted in co-operation with the University of Tampere.
This study will not affect any treatment or care, to any study subjects and it shall not have any impact on the duties of the clinical staff at the places of data gathering.
- Conditions
- Blood Pressure Measurement
- Being tested
- rPPG blood pressure measurement medical device software
- Keywords
- blood pressure, remote photoplethysmography, rppg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rPPG blood pressure measurement medical device softwareDevice
The investigational blood pressure measuring device uses remote photoplethysmography from video and does not use an inflatable arm cuff.
| Study group | Role | What they receive |
|---|---|---|
| Adults Undergoing Blood Pressure Validation Testing | Adult participants undergoing blood pressure measurements with the investigational blood pressure device and reference blood pressure assessment for evaluation of measurement accuracy. Receives: Device: rPPG blood pressure measurement medical device software |
What is being measured
The primary outcome is the main question the study is designed to answer.
SBP criterion 1: Mean difference and standard deviation between cuffless device systolic blood pressure and reference blood pressure measurement.
The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019).
Measured: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded.
DBP criterion 1: Mean difference and standard deviation between cuffless device diastolic blood pressure and reference blood pressure measurement.
The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019).
Measured: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded
Secondary outcomes (1)
Criterion 2: Inter-subject variability of device-reference blood pressure differences
The standard deviation of participant-level mean differences between cuffless device blood pressure measurements and reference blood pressure measurements is in accordance with table 1 of 5.2.4.1.2 (b) from ISO 81060-2:2019+A2:2024
Measured: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start11 May 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure MeasurementStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evondos Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Antti Vehkaoja, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739667
- Sponsor's protocol ID
- R24104L
- Status last verified
- Apr 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Measurement Using Vitacam
- ClinicalTrials.gov ID
- NCT07739667
- Acronym / sponsor ID
- R24104L
- Conditions
- Blood Pressure Measurement
- Keywords
- blood pressure, remote photoplethysmography, rppg
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Evondos OyIndustry (pharma, biotech, devices)
- Collaborators
- Tampere University
- Study start
- 11 May 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 31 Jul 2026 (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 clinical investigation is to collect data for the development, testing, and validation of a blood pressure measurement algorithm for a contactless vital signs monitor, Vitacam, according to the ISO 80601-2:2019 standard for validating non-invasive sphygmomanometer, with the intention of disseminating the validation results through a peer-reviewed scientific publication.
Detailed description
Vitacam is a Software-as-Medical Device (SaMD) for measuring vital physiological parameters from a video sequence from a face and chest, which uses computer vision techniques and remote photoplethysmography. This study concerns the development and validation of blood pressure measurements using Vitacam according to internationally recognised ISO (the International Organization for Standardization) standards with modifications imposed by cuffless measurements.
Based on these standards, measurements are collected simultaneously using Vitacam from facial videos, and a clinically validated auscultatory sphygmomanometer.
A minimum of 85 subjects are required for an EN ISO 81060-2:2019 + A2:2024 validation study with at least ≥30% of either sex. The SBP readings must be distributed such that ≥ 5% are ≤100 mmHG; ≥ 5% must be ≥ 160 and ≥ 20% is ≥ 140. The DBP readings must be distributed such that ≥ 5% are ≤60 mmHG; ≥ 5% must be ≥ 100 and ≥ 20% is ≥ 85. There must be at least 255 valid paired BP values.
The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019).
The standard deviation must also not exceed the value specified in Criterion 2 of the ISO standard, related to the mean difference to the reference BP.
Finally, a measuring device is considered acceptable if its estimated probability of a tolerable error (≤10mmHg) is at least 85%.
Vitacam is not intended for use in children and during pregnancy, so such subjects are excluded from the recruitment. It is intended to be used by elderly persons, so such subjects, able to give informed consent, will be recruited. As there is an increased prevalence of heart disease in the elderly, subjects diagnosed with atrial fibrillation or other irregular heart rhythms are neither excluded from the recruitment nor considered a special study population.
This study is a cross-sectional, observational, multi-site study conducted in co-operation with the University of Tampere.
This study will not affect any treatment or care, to any study subjects and it shall not have any impact on the duties of the clinical staff at the places of data gathering.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Undergoing Blood Pressure Validation Testing | – | Device: rPPG blood pressure measurement medical device softwareAdult participants undergoing blood pressure measurements with the investigational blood pressure device and reference blood pressure assessment for evaluation of measurement accuracy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents or visitors in the Tampere Pirkanmaa region
Key inclusion criteria (4 listed)
- Age 18 years or older
- Ability to give informed consent
- Volunteering for the study
- Fluent Finnish or English
Key exclusion criteria (4 listed)
- Age under 18 years
- Pregnancy
- Inability to give informed consent
- Denial
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 |
|---|---|---|
| rPPG blood pressure measurement medical device softwareThe investigational blood pressure measuring device uses remote photoplethysmography from video and does not use an inflatable arm cuff. | Device | Adults Undergoing Blood Pressure Validation Testing |
Primary outcome
SBP criterion 1: Mean difference and standard deviation between cuffless device systolic blood pressure and reference blood pressure measurement.
Time frame: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded.
The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019).
DBP criterion 1: Mean difference and standard deviation between cuffless device diastolic blood pressure and reference blood pressure measurement.
Time frame: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded
The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019).
1 secondary outcome
Criterion 2: Inter-subject variability of device-reference blood pressure differences
Time frame: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- 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.
Antti Vehkaoja principal investigator
Tampere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure Measurement, 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moyeen Ahmad (+35850486879, moyeen.ahmad@evondos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SBP criterion 1: Mean difference and standard deviation between cuffless device systolic blood pressure and reference blood pressure measurement. (time frame: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded.). 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 31 Jul 2026.