Hypertension Clinical Trial
Official title:
Clinical Evaluation of the Sotera VisiTM System for Measurement of Systolic and Diastolic Blood Pressures in Adults
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood pressure (BP) in adult subjects.
This study is a single-center blinded study that will enroll approximately 150 adult
subjects. Trained auscultators will perform the standard auscultation BP measurements. They
will be blinded to each other's measurements and from the ViSi measurements.
The study population will be randomized into two groups based on the side of the blood
pressure measurement: the left arm group (LAG) and the right arm group (RAG).
The randomization ratio of the LAG and RAG will be 1:1. There will be forced stratification
in order to ensure that the study subjects meet the required arm circumference and blood
pressure distributions as specified in the SP10:2008 and ISO 81060-2:2009(E) standards.
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