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Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound

NCT01704170 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2015-04-13

No results posted yet for this study

Summary

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 fifty patients who meet the inclusion and exclusion criteria and have signed the informed consent form. Safety is the primary endpoint of this study and 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 the secondary endpoint of this study and will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.

Conditions

Interventions

DEVICE

Kona Externally Focused Ultrasound Therapy

Sponsors & Collaborators

  • Kona Medical Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Australia
  • Canada
  • Czechia

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 NCT01704170 on ClinicalTrials.gov