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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01926951




Registration number
NCT01926951
Ethics application status
Date submitted
19/08/2013
Date registered
21/08/2013
Date last updated
29/10/2015

Titles & IDs
Public title
Renal Denervation Using Externally Focused Therapeutic Ultrasound
Scientific title
A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound With External Targeting and Tracking on Patients With Refractory Hypertension
Secondary ID [1] 0 0
KM13-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Surround Sound Externally Focused Therapeutic Ultrasound

Experimental: Renal Denervation - Renal Denervation using the Kona Surround Sound Externally Focused Therapeutic Ultrasound therapy.


Treatment: Devices: Surround Sound Externally Focused Therapeutic Ultrasound
Externally Focused Therapeutic Ultrasound using the Kona Surround Sound System

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
52-week post-treatment
Secondary outcome [1] 0 0
Clinical Utility - Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
Timepoint [1] 0 0
52-week post-treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Brno
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Prague
Country [3] 0 0
New Zealand
State/province [3] 0 0
Aukland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kona Medical Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01926951
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications