Renal Denervation Using Externally Focused Therapeutic Ultrasound

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT01926951
• Date of registration: 19/08/2013
• Prospective Registration: Yes
• Primary sponsor: Kona Medical Inc.
• Public title: Renal Denervation Using Externally Focused Therapeutic Ultrasound
• Scientific title: A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound With External Targeting and Tracking on Patients With Refractory Hypertension
• Date of first enrolment: September 2013
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01926951
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Czech Republic, New Zealand

Key inclusion & exclusion criteria

Inclusion Criteria:

- At least 18 years of age

- Average systolic blood pressure at least 160 mmHg

- Refractory, stable hypertension despite being treated with at least three
hypertensive drugs

- Two functioning kidneys, defined as eGFR >= 45 ml/min

- At least one renal artery on each side which is greater than 4 mm.

Exclusion Criteria:

- History of nephrectomy or hydronephrosis

- Renal stenosis > 50%

- Renal stent

- Ambulatory blood pressure monitoring 24 hour average systolic blood pressure <= 135
mmHg

- Kidney stones which are symptomatic and/or > 1 cm

- History of abdominal surgery within the past 6 months

- Heterogeneities in the kidneys (cysts or tumors)

- Residual pyelonephritis

- History of myocardial infarction, unstable angina pectoris, or cerebrovascular
accident within the last 6 months

- Hemodynamically significant valvular heart disease

- Implantable cardioverter defibrillator, pacemaker, neurostimulator or other device
incompatible with MRI

- Body weight > 150 kilograms

- Target treatment depth > 14 cm from the skin line

- Pregnant, nursing or intends to become pregnant during the trial period



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Device: Surround Sound Externally Focused Therapeutic Ultrasound

Primary Outcome(s)

Safety [Time Frame: 52-week post-treatment]

Secondary Outcome(s)

Clinical Utility [Time Frame: 52-week post-treatment]

Secondary ID(s)

KM13-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors