Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound

NCT ID: NCT01704170

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-06-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal Denervation Using Externally Focused Ultrasound Therapy

Group Type: EXPERIMENTAL

Kona Externally Focused Ultrasound Therapy

Intervention Type: DEVICE

Interventions

Kona Externally Focused Ultrasound Therapy

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kona Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Monash Medical Center

Melbourne, , Australia

St. Paul's Hospital

Vancouver, British Columbia, Canada

St. Anne's University Hospital

Brno, , Czechia

Nemocnice Na Homolee Hospital

Prague, , Czechia

Countries

Australia; Canada; Czechia

Other Identifiers

KM12-001

Identifier Type: -

Identifier Source: org_study_id