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Sham Controlled Study of Renal Denervation for Untreated Stage I and II Hypertension

NCT02480517 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-01-08

No results posted yet for this study

Summary

The Wave VI study is a, multicenter, prospective, double-blind, randomized, sham controlled feasibility study of the safety of renal denervation in patients with stage I and II hypertension who have an average office systolic blood pressure between 150 and 180 mmHg and have not been on any antihypertensive medications for at least six months.

Conditions

Interventions

DEVICE

Ultrasound

DEVICE

Sham Ultrasound

Sponsors & Collaborators

  • Kona Medical Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-03-31
Completion
2017-12-31

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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 NCT02480517 on ClinicalTrials.gov