Renal Denervation Using Externally Focused Therapeutic Ultrasound

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926951
• Other study ID #: KM13-001
• Status: Completed
• Phase: N/A
• First received: August 19, 2013
• Last updated: October 27, 2015
• Start date: September 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Kona Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Surround Sound Externally Focused Therapeutic Ultrasound
Externally Focused Therapeutic Ultrasound using the Kona Surround Sound System

Locations

Country	Name	City	State
Czech Republic	St. Anne's University Hospital	Brno
Czech Republic	Nemocnice Na Homolee Hospital	Prague
New Zealand	Mercy Angiography	Aukland

Sponsors (1)

Lead Sponsor	Collaborator
Kona Medical Inc.

Countries where clinical trial is conducted

Czech Republic,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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.	52-week post-treatment	Yes
Secondary	Clinical Utility	Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.	52-week post-treatment	No