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) (COR-BP)

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 Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure Monitoring, Ambulatory
• Intervention / Treatment: Device: Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2; Diagnostic test: Auscultatory blood pressure measurement

• Study Type: Observational
• Enrollment (Estimated): 170

Contacts and Locations

• Study Contact: Name: Nova Jaspers, MSc; Phone Number: +31616407778; Email: nova.jaspers@corsano.com
• Study Contact Backup: Name: Elena Ferraris, MSc; Email: elena@corsano.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Group A consists of patients 22 to 50 years of age. Group A involves patients from multiple demographic groups.	Device: Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2; Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2 wearable over a period of 31 days.; Other Names: non-invasive blood pressure; medical wearable; Diagnostic test: Auscultatory blood pressure measurement; Auscultatory blood pressure measurements in supine and sitting position.
Group B; Group B consists of patients aged 50 years and above. Group B involves patients from multiple demographic groups.	Device: Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2; Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2 wearable over a period of 31 days.; Other Names: non-invasive blood pressure; medical wearable; Diagnostic test: Auscultatory blood pressure measurement; Auscultatory blood pressure measurements in supine and sitting position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	31 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	31 days

Collaborators and Investigators

• Sponsor: Corsano Health B.V.
• Collaborators: Reinier de Graaf Groep

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Blood pressure; Remote monitoring; Wearable; Corsano CardioWatch
• Other Study ID Numbers: COR-BP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes