Renal Denervation Using Externally Focused Therapeutic Ultrasound
|ClinicalTrials.gov Identifier: NCT01926951|
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : October 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Device: Surround Sound Externally Focused Therapeutic Ultrasound||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926951
|St. Anne's University Hospital|
|Brno, Czech Republic|
|Nemocnice Na Homolee Hospital|
|Prague, Czech Republic|
|Aukland, New Zealand|