Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000895987
Ethics application status
Approved
Date submitted
22/08/2011
Date registered
22/08/2011
Date last updated
16/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Non-Therapeutic study to assess the Functionality of the Kona Renal Denervation System in Subjects Undergoing Diagnostic Angiography
Scientific title
A Non-Therapeutic Feasibility Pilot Study to Assess the Targeting and Tracking Functionality of the Kona Renal Denervation System in Subjects Undergoing Diagnostic Angiography
Secondary ID [1] 262877 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 270606 0
Condition category
Condition code
Cardiovascular 270767 270767 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Kona Renal Denervation System (RDS) is a focused therapeutic ultrasound system designed to administer catheter-guided, focused therapeutic ultrasound treatments to the sympathetic nerve complex of the renal artery to induce renal neurolysis (i.e., coagulation of the sympathetic nerves that innervate the kidneys). This Pilot study is intented to test the targeting and tracking function of the device only. The therapy (dosing) system components will be disabled in this pilot study. This research study will add between 15 to 30 minutes to the scheduled diagnostic angiography.
Intervention code [1] 269246 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279463 0
Assess the device-patient interface and renal artery targeting and tracking capability of the Kona Renal Denervation System (RDS) in patients who are undergoing diagnostic angiography via ultrasound
Timepoint [1] 279463 0
The ultrasound takes approximatley 5 minutes, and will occur after the routine angiography, just after the insertion of the Kona targeting catherter.
Secondary outcome [1] 287693 0
Nil
Timepoint [1] 287693 0
Nil

Eligibility
Key inclusion criteria
a. Subject is at least 18 years of age.
b. Subject is scheduled to undergo elective, diagnostic angiography.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Subject has a body weight > 150 kilograms.
b. Subject is pregnant, nursing or intends to become pregnant during the trial period.
c. Subject is currently enrolled in other potentially confounding research.
d. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269714 0
Commercial sector/Industry
Name [1] 269714 0
KONA Medical Inc.
Country [1] 269714 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Pacific Clinical Research Group
Address
Suite G03, 1 Cassins Ave
North Sydney, NSW 2060
Country
Australia
Secondary sponsor category [1] 268754 0
None
Name [1] 268754 0
Address [1] 268754 0
Country [1] 268754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271679 0
St Vincent's Hospital (Melbourne) HREC-D
Ethics committee address [1] 271679 0
PO Box 2900
Fitzroy VIC 3065
Ethics committee country [1] 271679 0
Australia
Date submitted for ethics approval [1] 271679 0
10/08/2011
Approval date [1] 271679 0
Ethics approval number [1] 271679 0
1/11/0101

Summary
Brief summary
The purpose of this study is to research one aspect, the non-therapeutic targeting and tracking functionality, of the Kona Renal Denervation System. The research project is being conducted to gather information about how the system functions when placed in a clinical setting. Information gathered from this research project will be used for the development of the Kona Renal Denervation System.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33045 0
Address 33045 0
Country 33045 0
Phone 33045 0
Fax 33045 0
Email 33045 0
Contact person for public queries
Name 16292 0
Anna Calleja
Address 16292 0
Project Manager
PO Box 1600
North Sydney NSW 2059
Country 16292 0
Australia
Phone 16292 0
+61 02 9925 4210
Fax 16292 0
Email 16292 0
anna.calleja@pcrg.com.au
Contact person for scientific queries
Name 7220 0
Thomas Anderson
Address 7220 0
Kona Medical Inc.
2495 140th Ave NE, Suite D100
Bellevue, WA 98005
Country 7220 0
United States of America
Phone 7220 0
+1 425 558 4616
Fax 7220 0
Email 7220 0
tanderson@konamedical.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.