Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound

A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound on Patients With Refractory Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Kona Externally Focused Ultrasound Therapy

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • Monash Medical Center
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • St. Paul's Hospital
• Czech Republic
  • Brno, Czech Republic
    • St. Anne's University Hospital
  • Prague, Czech Republic
    • Nemocnice Na Homolee Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is at least 18 years of age.
• Subject has systolic blood pressure of 160 mmHg in average or greater.
• Subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
• Subject has two functioning kidneys, defined as eGFR ≥ 45 ml/min.
• Subject has at least one renal artery on each side which is greater than 4mm.

Exclusion Criteria:

• Subject has hydronephrosis as seen on MRA or ultrasound.
• Subject has renal stenosis greater than 50% based on baseline MRA.
• Subject has a renal stent or other implant in the region.
• Subject has kidney stones which are symptomatic and/or greater than 1cm or in the discretion of the investigator may interfere with treatment.
• Subject has a history of abdominal surgery within the past six months.
• Subject has heterogeneities in the kidney such as large cysts or tumors which in the discretion of the investigator may interfere with treatment.
• Subject has active pyelonephritis or a history of pyelonephritis which in the discretion of the investigator may interfere with treatment.
• Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
• Subject has hemodynamically significant valvular heart disease.
• Subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI.
• Subject has a body weight > 150 kilograms.
• Subject has a target treatment depth > 14 cm.
• Subject is pregnant, nursing or intends to become pregnant during the trial period.
• Subject is currently enrolled in other potentially confounding research.
• Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Renal Denervation Using Externally Focused Ultrasound Therapy	Device: Kona Externally Focused Ultrasound Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Incidence of Adverse Events through 52 week follow-up	Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Included in this assessment will be the proportion of subjects with any of the following outcomes: (1) death, or (2) medical morbidity, including but not limited to renal artery aneurysm, stenosis, significant deterioration of renal function, fistulae or ureteral stenosis.	One Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Blood Pressure	Clinical utility will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.	12 and 24 weeks post therapy

Collaborators and Investigators

• Sponsor: Kona Medical Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: October 8, 2012
• First Submitted That Met QC Criteria: October 10, 2012
• First Posted (ESTIMATE): October 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 13, 2015
• Last Update Submitted That Met QC Criteria: April 10, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: KM12-001