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NCT03446664 · ClinicalTrials.gov registry record · NA
Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study
A NA study of Epilepsies, Partial and Epilepsy, Tonic-Clonic, sponsored by LivaNova.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
- 9
- Study locations
NCT03446664: Completed NA study of Epilepsies, Partial and Epilepsy, Tonic-Clonic, sponsored by LivaNova.
NCT03446664 is a NA study of Epilepsies, Partial and Epilepsy, Tonic-Clonic that has completed, run by LivaNova. The registered enrollment target is 33 participants, below the 64-participant average among 4 other Epilepsies, Partial trials with a reported enrollment target (48% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03446664, a NA study of Epilepsies, Partial and Epilepsy, Tonic-Clonic, has completed, sponsored by LivaNova.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
- 9
- Study locations
Study Summary
Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
Primary Outcome
For the primary endpoint, the change in the seizure frequency per month compared to baseline will be evaluated for each subject at follow-up visits month 6 and 12.
Conditions Studied
Interventions
- DEVICE Microburst Stimulation
Study Locations (9)
Illinois
- Rush University - Chicago
- Northwestern University - Evanston
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- University of Denver Colorado - Denver
Florida
- Mayo Clinic Florida - Jacksonville
New York
- Weil-Cornell Medical College - Ithaca
North Carolina
- Duke University - Durham
Utah
- University of Utah - Salt Lake City
Other
- Ghent University Hosptial - Ghent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2018-02-27 |
| Est. Completion | 2021-10-27 |
| Phase | NA |
What the finished NCT03446664 record still lists
NCT03446664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 64-participant average among 4 other Epilepsies, Partial trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Epilepsies, Partial appearing as the primary indexed condition, and to 1 intervention - of which Microburst Stimulation is the first listed.
NCT03446664 lists 9 locations in 8 states (Illinois, Alabama, Colorado).
Frequently Asked Questions
What is clinical trial NCT03446664 about?
NCT03446664 is a clinical study titled "Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study". Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
What is the current status of trial NCT03446664?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2018-02-27. Estimated completion is 2021-10-27.
What conditions does trial NCT03446664 study?
This clinical trial studies the following conditions: Epilepsies, Partial, Epilepsy, Tonic-Clonic.
What interventions are being tested in trial NCT03446664?
The interventions under investigation include: Microburst Stimulation (DEVICE).
Who is sponsoring clinical trial NCT03446664?
This trial is sponsored by LivaNova, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03446664 being conducted?
This trial has 9 study locations across Alabama, Colorado, Florida, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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