RNS System Post-Approval Study in Epilepsy
Study on Safety and Effectiveness of an Investigational System for Epilepsy
Brief description of study.
The purpose of this study is to follow subjects prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the RNS System at qualified Comprehensive Epilepsy Center by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System.
Detailed description of study
The purpose of this study is to follow subjects prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the RNS System at qualified Comprehensive Epilepsy Center by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: epilepsy
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Age: 100 years or below
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Gender: All
This study investigates the long-term safety and effectiveness of an investigational system designed for individuals with epilepsy. Epilepsy is a neurological disorder where brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensations, and sometimes loss of awareness.
Participants will be monitored in a real-world setting by qualified neurologists, epileptologists, and neurosurgeons at a Comprehensive Epilepsy Center. The study will collect data over a period of five years to assess the investigational system's impact.
- Who can participate: Participants must be adults diagnosed with epilepsy. Other eligibility criteria include a history of seizures and suitability for the investigational system.
- Study details: Participants will be observed by healthcare professionals trained in using the investigational system. Data will be collected to evaluate the system's safety and effectiveness.
- Study Timelines: The study will last 5 years.
Interested in the study?
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