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
  Purpose

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 Intervention
Hypertension
Device: Surround Sound Externally Focused Therapeutic Ultrasound

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 With External Targeting and Tracking on Patients With Refractory Hypertension

Resource links provided by NLM:


Further study details as provided by Kona Medical Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: September 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT01926951

Contacts
Contact: Kevin Peters kpeters@konamedical.com

Locations
Czech Republic
St. Anne's University Hospital Recruiting
Brno, Czech Republic
Contact: Tereza Mikusova, MD       tereza.mikusova@fnusa.cz   
Principal Investigator: Zdnek Starek, MD         
Nemocnice Na Homolee Hospital Recruiting
Prague, Czech Republic
Contact: Martina Goldbergová       Martina.Goldbergova@homolka.cz   
Principal Investigator: Petr Neuzil, M.D.         
New Zealand
Mercy Angiography Recruiting
Aukland, New Zealand
Contact: Barbara Joppa       Barbara@mercyangiography.co.nz   
Principal Investigator: John Ormiston, MD         
Sponsors and Collaborators
Kona Medical Inc.
  More Information

No publications provided

Responsible Party: Kona Medical Inc.
ClinicalTrials.gov Identifier: NCT01926951     History of Changes
Other Study ID Numbers: KM13-001
Study First Received: August 19, 2013
Last Updated: June 11, 2014
Health Authority: New Zealand: Medsafe

Keywords provided by Kona Medical Inc.:
hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 15, 2014