Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kona Medical Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
