An interventional study of Surround Sound Externally Focused Therapeutic Ultrasound in Hypertension, sponsored by Kona Medical Inc.. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-29.
Sponsored by Kona Medical Inc. · Not applicable, Interventional, and Treatment
This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 27 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Kona Medical Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Renal Denervation using the Kona Surround Sound Externally Focused Therapeutic Ultrasound therapy.
Device: Surround Sound Externally Focused Therapeutic Ultrasound
Externally Focused Therapeutic Ultrasound using the Kona Surround Sound System
Safety
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.
Time frame: 52-week post-treatment
Clinical Utility
Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
Time frame: 52-week post-treatment
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Kona Medical Inc.