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A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension

NCT01638195 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-04-13

No results posted yet for this study

Summary

This study is a prospective, single-institution trial wherein twenty subjects with refractory hypertension will receive the experimental focused ultrasound renal denervation therapy. Safety will be assessed by incidence and evaluation of serious adverse effects associated with the investigational procedure through 52-week evaluation of bilateral treatment. Clinical utility will also be evaluated by comparison pre and post therapy systolic and diastolic blood pressure and norepinephrine spillover.

Conditions

Interventions

DEVICE

Focused Ultrasound

Focused Ultrasound

Sponsors & Collaborators

  • Kona Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Whitbourn, M.D. · St Vincent's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01638195 on ClinicalTrials.gov