NCT01704170

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Nov 2012

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

Enrollment Period

1.6 years

First QC Date

October 8, 2012

Last Update Submit

April 10, 2015

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Decrease in Blood Pressure

    12 and 24 weeks post therapy

Study Arms (1)

Renal Denervation Using Externally Focused Ultrasound Therapy

EXPERIMENTAL
Device: Kona Externally Focused Ultrasound Therapy

Interventions

Kona Externally Focused Ultrasound TherapyDEVICE
Renal Denervation Using Externally Focused Ultrasound Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Monash Medical Center

Melbourne, Australia

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

St. Anne's University Hospital

Brno, Czechia

Location

Nemocnice Na Homolee Hospital

Prague, Czechia

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 11, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 13, 2015

Record last verified: 2015-04

Locations

CA(1)AU(1)CZ(2)