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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/NCT01638195




Registration number
NCT01638195
Ethics application status
Date submitted
8/07/2012
Date registered
11/07/2012
Date last updated
13/04/2015

Titles & IDs
Public title
A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension
Scientific title
A Feasibility Study: A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension
Secondary ID [1] 0 0
KM11-002
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 - Focused Ultrasound

Experimental: Externally Focused Ultrasound -


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

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
52 weeks post-treatment
Secondary outcome [1] 0 0
Blood Pressure Reduction
Timepoint [1] 0 0
52 weeks post-treatment

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

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

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

- Subject has two functioning kidneys, defined as eGFR = 60 ml/min.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has history of nephrectomy, kidney tumor or hydronephrosis.

- Subject has renal stenosis greater than 50%.

- Subject has presence of accessory renal artery with lumen = 3 mm.

- Subject has a renal stent.

- Subject has end stage renal disease requiring dialysis or renal implant.

- Subject has Serum Cr > 3.0 mg/dL or equivalent calculated Glomerular Filtration Rate
(GFR).

- Subject has a history of kidney stones.

- Subject has a history of abdominal surgery.

- Subject has a history of heterogeneities in the kidney such as cysts or tumors.

- Subject has a history of pyelonephritis.

- 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.

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
Phase 1
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
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

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, single-institution trial wherein twenty subjects with refractory
hypertension will receive the experimental focused ultrasound renal denervation therapy.
Safety will be assessed by incidence and evaluation of serious adverse effects associated
with the investigational procedure through 52-week evaluation of bilateral treatment.
Clinical utility will also be evaluated by comparison pre and post therapy systolic and
diastolic blood pressure and norepinephrine spillover.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01638195
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Whitbourn, M.D.
Address 0 0
St Vincent's Hospital
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/NCT01638195