A Non-Therapeutic study to assess the Functionality of the Kona Renal Denervation System in Subjects Undergoing Diagnostic Angiography

A Non-Therapeutic Feasibility Pilot Study to Assess the Targeting and Tracking Functionality of the Kona Renal Denervation System in Subjects Undergoing Diagnostic Angiography

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000895987

Enrollment

Registered

2011-08-22

Start date

2011-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 re

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

a. Subject is at least 18 years of age. b. Subject is scheduled to undergo elective, diagnostic angiography.

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.

Outcome results