Multi-Centre based evaluation of the performance and safety of the Corsano CardioWatch 287-2 blood pressure monitoring device at wrist against auscultatory blood pressure measurements

Rationale
Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor blood pressure. The device has been validated using clinical trials in hospitals, however further evaluation in the intended remote setting across various demographic groups is required.

Study Design
Multi-center, single-arm, diagnostic accuracy study, conducted at one site in Europe, one clinical research site in the United States, and one in South-Africa.

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, including evaluation of measurement stability and response to induced blood pressure changes.

Secondary objective
To assess the usability of the Corsano CardioWatch 287-2 from a patient perspective in a remote care setting.

Study population
Participants receiving multiple standardized paired auscultatory and Corsano CardioWatch blood pressure measurements over a 31-day period. Two age-based groups: Group A (22–50 years) and Group B (over 50 years).

Main study parameters/endpoints
Bias and limits of agreement between blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by conventional auscultation.

Secondary study parameters/endpoints
Usability of the Corsano CardioWatch 287-2 in a remote care setting.

Number of Participants
170 (40 in the Netherlands, 100 in the United States, 30 in South-Africa), across three in-clinic visits (Day 1, Midpoint, Day 31), including a handgrip-exercise challenge on Day 31 to assess dynamic blood pressure change detection.

Inclusion / Exclusion criteria
Inclusion: able to give informed consent; willing to complete 3 visits; 22 years or older; Dutch or English speaking.
Exclusion: compromised circulation/injury at sensor sites; known/possible pregnancy; clotting disorders or blood thinners; sustained arrhythmias (resting HR >120 bpm, AF); conditions reducing peripheral perfusion (e.g., Raynaud's, diabetes, renal dysfunction); aortic arch pathology; wrist circumference <14 or >23 cm; upper arm circumference <22 or >42 cm; lateral BP difference at screening >15/10 mmHg.

Study Centres
Reinier de Graaf Gasthuis, Delft (NL); Medicross Langeberg, Cape Town (SA); Cena Research Institute, Houston, TX (USA)

Start time, Duration
March 2026 – September 2026

Interested in our Trial Programme?

Corsano Cardiowatch Bracelets enable continuous monitoring with multiple algorithms. Corsano is working closely with cardiologists, scientists, hospitals, patients, and research organisations.  Scientific research demonstrates the legitimacy of Cardiowatch 287 algorithms. 

We are currently performing pilots with selected clients. Contact us if you want to know more!

Corsano CardioWatch is a wrist worn medical grade multi sensor bracelet to capture up to 19 vital parameters. Primary use cases are 24/7 continuous clinical trials and remote patient monitoring.  
 
The bracelet monitor offers flexibility to set data collection intervals by minute, by second or 25Hz, 32 Hz or 128 Hz. We measure Heart Rate, RR intervals, Breathing Rate, A-Fib detection, Skin Temperature, Activity and Sleep. SpO2, Core Body Temperature, ECG and Blood Pressure are in development.  
 
Clinical accuracy is paramount for us. In addition to third parties' algorithms, i.e. from Philips, we run our proprietary algorithms to realize superior data accuracy. Corsano technology has been clinically validated in major academic hospitals. The bracelet is manufactured under ISO 13485 and CE-MDR compliance. The process for FDA Clearance has started. 
 
Our end-to-end solution consists of light-weight and comfortable bracelets with a patient research portal. We have developed and produced over 200’000 devices. The Corsano platform has been optimized on connections, data buffers and battery life up to 15 days. We offer access to raw continuous high frequency data through API and cloud-to-cloud solutions. 
 

The founders of Corsano Health have over 100 years of experience in the Swiss Watch industry, with deep experience about ergonomic design and materials for wearables that are worn 24/7.