Feasibility Study to Evaluate Renal Denervation Using Foc... | NCT01704170

Studies
Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound

NCT01704170

Sponsor

Kona Medical Inc.

Status

Completed

Last Update Posted

Apr 13, 2015Estimated

Enrollment

31Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Kona Externally Focused Ultrasound Therapy

Countries

Australia
Canada
Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Oct 8, 2012

First Submission Date that Met QC Criteria

Oct 10, 2012

First Posted Date

Oct 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2015

Last Update Posted Date

Apr 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Label	Type	Description	Intervention Names
Renal Denervation Using Externally Focused Ultrasound Therapy	Experimental		Device: Kona Externally Focused Ultrasound Therapy

Name	Type	Description	Arm Group Labels	Other Names
Kona Externally Focused Ultrasound Therapy	Device		Renal Denervation Using Externally Focused Ultrasound Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety: Incidence of Adverse Events through 52 week follow-up	Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Included in this assessment will be the proportion of subjects with any of the following outcomes: (1) death, or (2) medical morbidity, including but not limited to renal artery aneurysm, stenosis, significant deterioration of renal function, fistulae or ureteral stenosis.	One Year

Secondary Outcomes

Measure	Description	Time Frame
Decrease in Blood Pressure	Clinical utility will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.	12 and 24 weeks post therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Monash Medical Center		Melbourne			Australia
St. Paul's Hospital

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases