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
1 other identifier
interventional
27
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Sep 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2013
CompletedFirst Posted
Study publicly available on registry
August 21, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 29, 2015
October 1, 2015
1.7 years
August 19, 2013
October 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
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.
52-week post-treatment
Secondary Outcomes (1)
Clinical Utility
52-week post-treatment
Study Arms (1)
Renal Denervation
EXPERIMENTALRenal Denervation using the Kona Surround Sound Externally Focused Therapeutic Ultrasound therapy.
Interventions
Externally Focused Therapeutic Ultrasound using the Kona Surround Sound System
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
St. Anne's University Hospital
Brno, Czechia
Nemocnice Na Homolee Hospital
Prague, Czechia
Mercy Angiography
Aukland, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2013
First Posted
August 21, 2013
Study Start
September 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
October 29, 2015
Record last verified: 2015-10