Smartwatch-Style BP monitor put to the test against standard cuff
NCT ID NCT07633886
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a medical wrist device called the Corsano CardioWatch 287-2 that measures blood pressure. Researchers will compare its readings to standard arm-cuff measurements in 170 adults over 31 days. The goal is to see if the device works accurately for home monitoring across different ages and backgrounds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Corsano CardioWatch 287-2 wearable blood pressure monitor
- What this could lead to
- If successful, this could provide a reliable way for people to monitor their blood pressure at home using a wrist device, making tracking easier and more convenient.
- What could go wrong
- This is an early-stage validation study with only 170 participants. The device may not be as accurate as standard cuffs for all users, and results may not apply to everyone.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 170 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula. * 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)
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As listed by the trial registrant
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How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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