Renal Denervation Using Externally Focused Therapeutic Ultrasound

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Kona Medical Inc.
Sponsor:
Information provided by (Responsible Party):
Kona Medical Inc.
ClinicalTrials.gov Identifier:
NCT01926951
First received: August 19, 2013
Last updated: June 11, 2014
Last verified: June 2014

August 19, 2013
June 11, 2014
September 2013
April 2015   (final data collection date for primary outcome measure)
Safety [ Time Frame: 52-week post-treatment ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01926951 on ClinicalTrials.gov Archive Site
Clinical Utility [ Time Frame: 52-week post-treatment ] [ Designated as safety issue: No ]
Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
Same as current
Not Provided
Not Provided
 
Renal Denervation Using Externally Focused Therapeutic Ultrasound
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Device: Surround Sound Externally Focused Therapeutic Ultrasound
Externally Focused Therapeutic Ultrasound using the Kona Surround Sound System
Experimental: Renal Denervation
Renal Denervation using the Kona Surround Sound Externally Focused Therapeutic Ultrasound therapy.
Intervention: Device: Surround Sound Externally Focused Therapeutic Ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kevin Peters kpeters@konamedical.com
Czech Republic,   New Zealand
 
NCT01926951
KM13-001
Yes
Kona Medical Inc.
Kona Medical Inc.
Not Provided
Not Provided
Kona Medical Inc.
June 2014

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