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.
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.
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.
Corsano Health B.V.
Lead sponsor
Reinier de Graaf Groep
Collaborator