Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Bloo… (NCT07633886) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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)
170 participantsStarted 2026-06
Plain-language 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 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.
Who can participate
Age range
22 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 pe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.