Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kona Medical Inc.
ClinicalTrials.gov Identifier:
NCT01704170
First received: October 8, 2012
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Hypertension
Device: Kona Externally Focused Ultrasound Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound on Patients With Refractory Hypertension

Resource links provided by NLM:


Further study details as provided by Kona Medical Inc.:

Primary Outcome Measures:
  • Safety: Incidence of Adverse Events through 52 week follow-up [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Decrease in Blood Pressure [ Time Frame: 12 and 24 weeks post therapy ] [ Designated as safety issue: No ]
    Clinical utility will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Denervation Using Externally Focused Ultrasound Therapy Device: Kona Externally Focused Ultrasound Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01704170

Locations
Australia
Monash Medical Center
Melbourne, Australia
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Czech Republic
St. Anne's University Hospital
Brno, Czech Republic
Nemocnice Na Homolee Hospital
Prague, Czech Republic
Sponsors and Collaborators
Kona Medical Inc.
  More Information

No publications provided

Responsible Party: Kona Medical Inc.
ClinicalTrials.gov Identifier: NCT01704170     History of Changes
Other Study ID Numbers: KM12-001
Study First Received: October 8, 2012
Last Updated: June 11, 2014
Health Authority: Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014