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RNS® System Epilepsy Post-Approval Study
NCT02403843 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the study is to follow patients with partial onset seizures 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 CECs by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System.
Conditions Studied
Interventions
- DEVICE RNS System
Study Locations (20)
California
- University of California, Irvine — Irvine
- University of Southern California — Los Angeles
- University of California, Los Angeles — Los Angeles
- Stanford University — Palo Alto
- University of California, San Francisco — San Francisco
Kentucky
- University of Kentucky — Lexington
- Norton Neuroscience Institute — Louisville
Alabama
- University of Alabama, Birmingham — Birmingham
Colorado
- University of Colorado Denver — Aurora
Connecticut
- Yale University — New Haven
Florida
- University of South Florida — Tampa
Georgia
- Emory University — Atlanta
Illinois
- Rush University Medical Center — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2015-06 |
| Est. Completion | 2026-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02403843
The ClinicalTrials.gov registry entry for NCT02403843 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 375 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NeuroPace, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 1 intervention — of which RNS System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02403843 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Kentucky, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02403843 about?
NCT02403843 is a clinical study titled "RNS® System Epilepsy Post-Approval Study". The purpose of the study is to follow patients with partial onset seizures 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 CECs by qualified neurologists, epileptologists, and neurosurgeons trained on th...
What is the current status of trial NCT02403843?
This trial is currently active not recruiting. The enrollment target is 375 participants. The study started on 2015-06. Estimated completion is 2026-01.
What conditions does trial NCT02403843 study?
This clinical trial studies the following conditions: Epilepsy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02403843?
The interventions under investigation include: RNS System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02403843?
This trial is sponsored by NeuroPace, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02403843 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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