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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
52-week post-treatment
Secondary outcome [1] 0 0
Clinical Utility
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
Sex
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
Not applicable
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
1/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
27
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01926951