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Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension

NCT02029885 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2016-01-08

No results posted yet for this study

Summary

To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.

Conditions

Interventions

DEVICE

Investigational Therapy (Surround Sound)

DEVICE

Sham Control

Sponsors & Collaborators

  • Kona Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Roland Schmieder, MD · University Hospital of University of Erlangen-Nuremberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-03-31
Completion
2018-03-31

Countries

  • Australia
  • Austria
  • Colombia
  • Czechia
  • Germany
  • New Zealand
  • Poland
  • United Kingdom

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 NCT02029885 on ClinicalTrials.gov