Renal Denervation Using Externally Focused Therapeutic Ultrasound

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: Surround Sound Externally Focused Therapeutic Ultrasound

• Registration Number: NCT01926951
• Lead Sponsor: Kona Medical Inc.

Brief Summary

This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.

Detailed Description

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 Timeline

• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-21
• Study Start: 2013-09
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• At least 18 years of age
• Average systolic blood pressure at least 160 mmHg
• Refractory, stable hypertension despite being treated with at least three hypertensive drugs
• Two functioning kidneys, defined as eGFR >= 45 ml/min
• At least one renal artery on each side which is greater than 4 mm.

Exclusion Criteria

• History of nephrectomy or hydronephrosis
• Renal stenosis > 50%
• Renal stent
• Ambulatory blood pressure monitoring 24 hour average systolic blood pressure <= 135 mmHg
• Kidney stones which are symptomatic and/or > 1 cm
• History of abdominal surgery within the past 6 months
• Heterogeneities in the kidneys (cysts or tumors)
• Residual pyelonephritis
• History of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last 6 months
• Hemodynamically significant valvular heart disease
• Implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI
• Body weight > 150 kilograms
• Target treatment depth > 14 cm from the skin line
• Pregnant, nursing or intends to become pregnant during the trial period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Surround Sound Externally Focused Therapeutic Ultrasound	Renal Denervation using the Kona Surround Sound Externally Focused Therapeutic Ultrasound therapy.

Primary Outcome Measures

Name	Time	Method
Safety	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Utility	52-week post-treatment	Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.

Trial Locations

Locations (3)

Nemocnice Na Homolee Hospital; 🇨🇿 Prague, Czech Republic

St. Anne's University Hospital; 🇨🇿 Brno, Czech Republic

Mercy Angiography; 🇳🇿 Aukland, New Zealand