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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01704170




Registration number
NCT01704170
Ethics application status
Date submitted
8/10/2012
Date registered
11/10/2012
Date last updated
13/04/2015

Titles & IDs
Public title
Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound
Scientific title
A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound on Patients With Refractory Hypertension
Secondary ID [1] 0 0
KM12-001
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 - Kona Externally Focused Ultrasound Therapy

Experimental: Renal Denervation Using Externally Focused Ultrasound Therapy -


Treatment: Devices: Kona Externally Focused Ultrasound Therapy
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: Incidence of Adverse Events through 52 week follow-up
Timepoint [1] 0 0
One Year
Secondary outcome [1] 0 0
Decrease in Blood Pressure
Timepoint [1] 0 0
12 and 24 weeks post therapy

Eligibility
Key inclusion criteria
- Subject is at least 18 years of age.

- Subject has systolic blood pressure of 160 mmHg in average or greater.

- Subject has refractory, stable hypertension despite being treated with at least three
hypertensive drugs.

- Subject has two functioning kidneys, defined as eGFR = 45 ml/min.

- Subject has at least one renal artery on each side which is greater than 4mm.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has hydronephrosis as seen on MRA or ultrasound.

- Subject has renal stenosis greater than 50% based on baseline MRA.

- Subject has a renal stent or other implant in the region.

- Subject has kidney stones which are symptomatic and/or greater than 1cm or in the
discretion of the investigator may interfere with treatment.

- Subject has a history of abdominal surgery within the past six months.

- Subject has heterogeneities in the kidney such as large cysts or tumors which in the
discretion of the investigator may interfere with treatment.

- Subject has active pyelonephritis or a history of pyelonephritis which in the
discretion of the investigator may interfere with treatment.

- Subject has a history of myocardial infarction, unstable angina pectoris, or
cerebrovascular accident within the last six months.

- Subject has hemodynamically significant valvular heart disease.

- Subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or
other device incompatible with MRI.

- Subject has a body weight > 150 kilograms.

- Subject has a target treatment depth > 14 cm.

- Subject is pregnant, nursing or intends to become pregnant during the trial period.

- Subject is currently enrolled in other potentially confounding research.

- Subject has any condition that, at the discretion of the investigator, would preclude
participation in the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Center - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Brno
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Prague

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

Ethics approval
Ethics application status

Summary
Brief summary
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 fifty patients who meet the inclusion and exclusion criteria and
have signed the informed consent form. Safety is the primary endpoint of this study and 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 the secondary
endpoint of this study and will be evaluated by assessing pre and post therapy systolic and
diastolic blood pressure.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01704170
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01704170