Trials / Completed
CompletedNCT03529045
Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.
CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 827 (actual)
- Sponsor
- LivaNova · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vagus Nerve Stimulation (VNS) Therapy | The VNS Therapy System is a commercially available device that will be used by licensed medical practitioners trained in the use of VNS Therapy, per the practitioners' medical judgement. |
Timeline
- Start date
- 2018-02-05
- Primary completion
- 2024-09-11
- Completion
- 2024-09-11
- First posted
- 2018-05-18
- Last updated
- 2024-11-22
Locations
62 sites across 16 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, India, Israel, Italy, Japan, Netherlands, Poland, Portugal, Saudi Arabia, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03529045. Inclusion in this directory is not an endorsement.