Hypertension
Conditions
Keywords
hypertension
Brief summary
This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.
Detailed description
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 twenty patients who meet the eligibility criteria and have signed the informed consent form. Safety is the primary endpoint of this study. Safety 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 a secondary endpoint of this study. Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
Interventions
DEVICESurround Sound Externally Focused Therapeutic Ultrasound
Externally Focused Therapeutic Ultrasound using the Kona Surround Sound System
Sponsors
Kona Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 52-week post-treatment | Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through 52-week evaluation. Included in this assessment will be the proportion of subjects with any of the following outcomes: 1) death, or 2) medical morbidity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Utility | 52-week post-treatment | Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure. |
Countries
Czechia, New Zealand
Outcome results
None listed