People with high blood pressure may be on blood pressure lowering medications or they may not be on any medication. There are two groups in the study – the SOLO Cohort and the TRIO Cohort. The results of this study may be used to help the Food and Drug Administration (FDA) determine if the device should be approved in the USA.
The SOLO Cohort has completed enrollment and preliminary results are available. The TRIO Cohort is still enrolling patients. You are being considered for enrollment in the TRIO cohort
The Paradise System is a medical device made by a company called ReCor Medical Inc., based in Palo Alto, California in the USA. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven’t been approved by the FDA.
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