Renal Denervation Using Externally Focused Therapeutic Ultrasound
|Hypertension||Device: Surround Sound Externally Focused Therapeutic Ultrasound|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound With External Targeting and Tracking on Patients With Refractory Hypertension|
- Safety [ Time Frame: 52-week post-treatment ]Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through 52-week evaluation. Included in this assessment will be the proportion of subjects with any of the following outcomes: 1) death, or 2) medical morbidity.
- Clinical Utility [ Time Frame: 52-week post-treatment ]Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
|Study Start Date:||September 2013|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Renal Denervation
Renal Denervation using the Kona Surround Sound Externally Focused Therapeutic Ultrasound therapy.
Device: Surround Sound Externally Focused Therapeutic Ultrasound
Externally Focused Therapeutic Ultrasound using the Kona Surround Sound System
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 twenty patients who meet the eligibility criteria and have signed the informed consent form.
Safety is the primary endpoint of this study. Safety 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 a secondary endpoint of this study. Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01926951
|St. Anne's University Hospital|
|Brno, Czech Republic|
|Nemocnice Na Homolee Hospital|
|Prague, Czech Republic|
|Aukland, New Zealand|