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A Study to Evaluate Safety and Efficacy of the Redy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension

NCT02690909 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2016-05-11

No results posted yet for this study

Summary

The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of ablation features and technical improvements over previously designed systems into a single product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of the sympathetic nerve network surrounding the renal arteries.

This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal Denervation device and to demonstrate that it performs according to its intended use, i.e. the treatment of patients with uncontrolled hypertension.

Conditions

  • Hypertension Resistant to Conventional Therapy

Interventions

DEVICE

Redy™ Renal Denervation System

Renal Denervation System

Sponsors & Collaborators

  • Biosensors Europe SA

    collaborator INDUSTRY

  • Physio-Logic Ltd. Israel

    collaborator UNKNOWN

  • AmeRuss Clinical Trials LLC, USA

    collaborator UNKNOWN

  • Renal Dynamics GmbH

    lead INDUSTRY

Principal Investigators

  • Felix Mahfoud, MD · Saarland University Medical Center Homburg, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-04-30
Completion
2017-08-31

Countries

  • Belgium
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Poland
  • Russia
  • Serbia

Study Locations

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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 NCT02690909 on ClinicalTrials.gov