Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound

Status Completed

Clinical Trial Summary

This study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy. It will be conducted on a maximum of fifty patients who meet the inclusion and exclusion criteria and have signed the informed consent form. Safety is the primary endpoint of this study and will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation. Clinical utility is the secondary endpoint of this study and will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Hypertension

Clinical Trial Details

NCT number	NCT01704170
Study type	Interventional
Source	Kona Medical Inc.
Contact
Status	Completed
Phase	N/A
Start date	November 2012
Completion date	June 2014

View Details

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