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

Completed

Conditions studied: Epilepsy, Seizures, Drug Resistant Epilepsy

In brief

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

Key facts

Study ID

NCT03529045

Run by

LivaNova

People needed

827

Starts

2018-02-05

Expected to finish

2024-09-11

Last updated by the study team

2024-11-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Research Institute of Orlando — Orlando, Florida, United States
• Pediatric Epilepsy & Neurology Specialists — Tampa, Florida, United States
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
• Via Christi Health — Wichita, Kansas, United States
• Tulane University — New Orleans, Louisiana, United States
• Dent Neurosciences Research Center — Amherst, New York, United States
• State University of New York — Syracuse, New York, United States
• Duke University Hospital — Durham, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny Neurology Associates — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States
• Child Neurology Consultants of Austin — Austin, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Valley Health System — Winchester, Virginia, United States
• Ascension Columbia St. Mary's Hospital — Milwaukee, Wisconsin, United States
• Queensland Children's hospital — Brisbane, Queensland, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• The Royal Melbourne Hospital — Melbourne, Victoria, Australia
• Royal Children's hospital — Melbourne, Victoria, Australia
• Perth Children's Hospital — Perth, Western Australia, Australia
• Kepler Universitätsklinikum — Linz, Austria
• St. Mary's Hospital — Grand Junction, Colorado, United States

Full record on ClinicalTrials.gov

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