Renal Denervation Using Externally Focused Therapeutic Ultrasound

October 27, 2015 updated by: Kona Medical Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic
        • St. Anne's University Hospital
      • Prague, Czech Republic
        • Nemocnice Na Homolee Hospital
  • New Zealand
      • Aukland, New Zealand
        • Mercy Angiography

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52-week post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Utility
Time Frame: 52-week post-treatment
Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
52-week post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kona Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 21, 2013

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KM13-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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