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Renal Denervation Using Externally Focused Therapeutic Ultrasound

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ClinicalTrials.gov Identifier: NCT01926951
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Kona Medical Inc.

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

Condition or disease Intervention/treatment Phase
Hypertension Device: Surround Sound Externally Focused Therapeutic Ultrasound Not Applicable

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  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound With External Targeting and Tracking on Patients With Refractory Hypertension
Study Start Date : September 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical Utility [ Time Frame: 52-week post-treatment ]
    Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926951


Locations
Czech Republic
St. Anne's University Hospital
Brno, Czech Republic
Nemocnice Na Homolee Hospital
Prague, Czech Republic
New Zealand
Mercy Angiography
Aukland, New Zealand
Sponsors and Collaborators
Kona Medical Inc.

Responsible Party: Kona Medical Inc.
ClinicalTrials.gov Identifier: NCT01926951     History of Changes
Other Study ID Numbers: KM13-001
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015

Keywords provided by Kona Medical Inc.:
hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases