Blood Pressure Monitoring, AmbulatoryCOR-BPNCT07633886
Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)
An observational study of Blood Pressure Monitoring, Ambulatory, run by Corsano Health B.V..
Trial summary
The Corsano CardioWatch 287-2 is a medical wearable device that can monitor blood pressure. The device has been validated using clinical trials in hospitals. The aim of this study is to further evaluate blood pressure measurements by the CardioWatch 287-2 in the intended remote setting across various demographic… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Blood Pressure Monitoring, Ambulatory
- What is being tested?
- Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2 and Auscultatory blood pressure measurement
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Sep 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will involve one patient group (70 patients), visiting the outpatient cardiology clinic at the Reinier de Graaf Gasthuis (NL), one patient group (100 patients) visiting the outpatient clinic of the CENA Research Institute Houston (TX, USA). These demographic groups are both split into group A and B. Group A consists of patients 22 to 50 years of age and group B consists of patients aged 50 years and above.
Who may be able to join
- Participants must be able to provide informed consent to participate.
- Participants must be willing and able to comply with all of the study procedures and return for at least 3 visits.
- Participant or witness must be able to read or write in Dutch or English.
- Applicable for group A: Participant must be 22 to 50 years of age.
- Applicable for group B: Participant must be over 50 years of age.
Who cannot join
- Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized).
- Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.
- Participants with known clotting disorders or currently taking a prescription blood thinner.
- Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
- Participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation.
- Participants suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula.
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- Participants with known aortic arch pathology or prior surgical intervention involving the aortic arch or descending aorta (e.g., coarctation repair, vascular grafting, or stenting), which may interfere either with accurate peripheral blood pressure measurement.
- A wrist circumference below 14 cm or above 23 cm.
- An upper arm circumference < 22cm or > 42cm.
- Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study (i.e. to ensure all sub-groups have adequate representation).
- Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and/or more than 10 mmHg for the diastolic.
- Additional criteria that will be pursued for ensuring demographic diversity consist of the following patient characteristics according to FDA recommendations concerning the diversity of clinical trial populations [6]:
- Gender, at least:
- 40% female;
- 40% male.
- Skin Colour, at least:
- 25% Monk skin tone (MST) 1-3;
- 25% MST 4-6;
- 25% MST 7-10 including subjects with MST 9 and MST 10.
- BMI, at least:
- 5% Underweight (<18.5)
- 20% Normal weight (18.5-24.9)
- 20% Overweight (25-29.9)
- 20% Obese (≥30.0)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Elena Ferraris, MSc contact
About this study
The Corsano CardioWatch 287-2 is a medical wearable device that can monitor blood pressure. The device has been validated using clinical trials in hospitals. The aim of this study is to further evaluate blood pressure measurements by the CardioWatch 287-2 in the intended remote setting across various demographic groups.
Primary objective: To assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and auscultatory blood pressure monitoring over a period of 31 days.
Read more
Secondary objective: To assess the usability of the Corsano CardioWatch 287-2 from a patient perspective.
Participants receiving multiple standardized paired auscultatory and Corsano CardioWatch blood pressure measurements over a 31-day period. The study group will include patients of different ages (above the age of 22 years), genders, and demographics.
- Conditions
- Blood Pressure Monitoring, Ambulatory
- Being tested
- Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2, Auscultatory blood pressure measurement
- Keywords
- Blood pressure, Remote monitoring, Wearable, Corsano CardioWatch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2Device
Also called medical wearable, non-invasive blood pressure
Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2 wearable over a period of 31 days.
Auscultatory blood pressure measurementDiagnostic test
Auscultatory blood pressure measurements in supine and sitting position.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A consists of patients 22 to 50 years of age. Group A involves patients from multiple demographic groups. Receives: Device: Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2; Diagnostic Test: Auscultatory blood pressure measurement | |
| Group B | Group B consists of patients aged 50 years and above. Group B involves patients from multiple demographic groups. Receives: Device: Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2; Diagnostic Test: Auscultatory blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate blood pressure measurements Corsano CardioWatch 287-2
The main objective of this study is to assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and the gold standard auscultatory measurements over a 31-day calibration interval, including evaluation of measurement stability and response to induced blood pressure changes. monitoring over a period of 31 days; to evaluate the performance of the Corsano CardioWatch 287-2.
Measured: 31 days
Secondary outcomes (1)
Assess usability
The secondary objective of this study is to assess the usability of the Corsano CardioWatch 287-2 from a patient perspective in a remote care setting. This will be done by using a questionnaire that assesses the usability, comfort, and noticeability of wearing the CardioWatch 287-2.
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure Monitoring, AmbulatoryStudies 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
- Retrospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corsano Health B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reinier de Graaf Groep
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633886
- Sponsor's protocol ID
- COR-BP
- Acronym
- COR-BP
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)
- ClinicalTrials.gov ID
- NCT07633886
- Acronym / sponsor ID
- COR-BP / COR-BP
- Conditions
- Blood Pressure Monitoring, Ambulatory
- Keywords
- Blood pressure, Remote monitoring, Wearable, Corsano CardioWatch
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Corsano Health B.V.Industry (pharma, biotech, devices)
- Collaborators
- Reinier de Graaf Groep
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Jun 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 Corsano CardioWatch 287-2 is a medical wearable device that can monitor blood pressure. The device has been validated using clinical trials in hospitals. The aim of this study is to further evaluate blood pressure measurements by the CardioWatch 287-2 in the intended remote setting across various demographic groups.
Primary objective: To assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and auscultatory blood pressure monitoring over a period of 31 days.
Secondary objective: To assess the usability of the Corsano CardioWatch 287-2 from a patient perspective.
Participants receiving multiple standardized paired auscultatory and Corsano CardioWatch blood pressure measurements over a 31-day period. The study group will include patients of different ages (above the age of 22 years), genders, and demographics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2, Diagnostic Test: Auscultatory blood pressure measurementGroup A consists of patients 22 to 50 years of age. Group A involves patients from multiple demographic groups. |
| Group B | – | Device: Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2, Diagnostic Test: Auscultatory blood pressure measurementGroup B consists of patients aged 50 years and above. Group B involves patients from multiple demographic groups. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will involve one patient group (70 patients), visiting the outpatient cardiology clinic at the Reinier de Graaf Gasthuis (NL), one patient group (100 patients) visiting the outpatient clinic of the CENA Research Institute Houston (TX, USA). These demographic groups are both split into group A and B. Group A consists of patients 22 to 50 years of age and group B consists of patients aged 50 years and above.
Key inclusion criteria (5 listed)
- Participants must be able to provide informed consent to participate.
- Participants must be willing and able to comply with all of the study procedures and return for at least 3 visits.
- Participant or witness must be able to read or write in Dutch or English.
- Applicable for group A: Participant must be 22 to 50 years of age.
- Applicable for group B: Participant must be over 50 years of age.
Key exclusion criteria (24 listed)
- Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized).
- Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.
- Participants with known clotting disorders or currently taking a prescription blood thinner.
- Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
- Participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation.
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 |
|---|---|---|
| Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2Also: medical wearable, non-invasive blood pressureNon-invasive blood pressure measurements with the Corsano CardioWatch 287-2 wearable over a period of 31 days. | Device | Group A, Group B |
| Auscultatory blood pressure measurementAuscultatory blood pressure measurements in supine and sitting position. | Diagnostic test | Group A, Group B |
Primary outcome
Validate blood pressure measurements Corsano CardioWatch 287-2
Time frame: 31 days
The main objective of this study is to assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and the gold standard auscultatory measurements over a 31-day calibration interval, including evaluation of measurement stability and response to induced blood pressure changes. monitoring over a period of 31 days; to evaluate the performance of the Corsano CardioWatch 287-2.
1 secondary outcome
Assess usability
Time frame: 31 days
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 8 Jun 2026.
- 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.
Elena Ferraris, MSc contact
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure Monitoring, Ambulatory, run by Corsano Health B.V..
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 24 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: opening soon, as of the sponsor's last update on 8 Jun 2026. 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?
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 Nova Jaspers, MSc (+31616407778, nova.jaspers@corsano.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate blood pressure measurements Corsano CardioWatch 287-2 (time frame: 31 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 8 Jun 2026.