Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.

  • STATUS
    Recruiting
  • End date
    Mar 31, 2027
  • participants needed
    2000
  • sponsor
    LivaNova
Updated on 6 May 2020
Investigator
Wim Van Grunderbeek
Primary Contact
Kempenhaege (0.0 mi away) Contact
+56 other location
epilepsy
vagal nerve stimulation
vagus nerve stimulation
intractable epilepsy

Summary

Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.

Description

The purpose of this registry is to evaluate clinical outcome and safety data in subjects with drug resistant epilepsy treated with the VNS Therapy System. The study will collect outcomes for subjects treated with VNS Therapy in a real-world setting.

Details
Treatment Vagus Nerve Stimulation (VNS) Therapy
Clinical Study IdentifierNCT03529045
SponsorLivaNova
Last Modified on6 May 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Drug Resistant Epilepsy or Seizure Disorders or Seizure Disorders (Pediatric) or Seizure or Epilepsy?
Clinical diagnosis of drug resistant epilepsy treated with VNS Therapy. Eligible subjects include those not previously treated with VNS Therapy as well as subjects receiving replacement generators
Able and willing to comply with the frequency of study visits
Subject, or legal guardian, understands study procedures and voluntarily signs an informed consent in accordance with institutional policies. In the event that the subject is under the age of 18, the subject may also be required (per EC/IRB) to sign an assent affirming their agreement to participate

Exclusion Criteria

There are no exclusion criteria in this study. Investigators should refer to
the local instructions for use for VNS Therapy
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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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