Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound

This study is currently recruiting participants.
Verified January 2014 by Kona Medical Inc.
Sponsor:
Information provided by (Responsible Party):
Kona Medical Inc.
ClinicalTrials.gov Identifier:
NCT01704170
First received: October 8, 2012
Last updated: January 6, 2014
Last verified: January 2014

October 8, 2012
January 6, 2014
November 2012
May 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01704170 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Device: Kona Externally Focused Ultrasound Therapy
Experimental: Renal Denervation Using Externally Focused Ultrasound Therapy
Intervention: Device: Kona Externally Focused Ultrasound Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Keviin Peters kpeters@konamedical.com
Australia,   Canada,   Czech Republic
 
NCT01704170
KM12-001
No
Kona Medical Inc.
Kona Medical Inc.
Not Provided
Not Provided
Kona Medical Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP