RNS® System Pivotal Study
Public ClinicalTrials.gov record NCT00264810. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
RNS® System Pivotal-A Clinical Investigation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The RNS® System Pivotal study is designed to assess safety and demonstrate that the RNS® System is effective as an adjunctive (add-on) therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci (two areas of the brain) that are refractory (drug-resistant or hard-to-treat) to two or more antiepileptic medications. Patients continue to receive their epilepsy medications while participating in the study.
Study identification
- NCT ID
- NCT00264810
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 240 participants
Conditions and interventions
Conditions
Interventions
- RNS® System implantation Procedure
- RNS® System responsive stimulation Device
Procedure · Device
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2005 (Type not available)
- Primary completion
- Oct 2009 (Actual)
- Completion
- May 2011 (Actual)
- Last update posted
- Aug 28, 2013
2005 – 2011
United States locations
- U.S. sites
- 32
- U.S. states
- 26
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Mayo Clinic - Arizona | Phoenix | Arizona | 85054 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| George Washington University | Washington D.C. | District of Columbia | 20037 | — |
| University of Florida at Gainesville | Gainesville | Florida | 32610 | — |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | — |
| Miami Children's Hospital | Miami | Florida | 33155 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Medical College of Georgia / Georgia Health Sciences University | Augusta | Georgia | 30912 | — |
| Rush University Medical Center/ Epilepsy Center | Chicago | Illinois | 60612 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Via Christi Comprehensive Epilepsy Center | Wichita | Kansas | 67214 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| Columbia University / Columbia Presbyterian Medical Center | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44145 | — |
| Oregon Health & Science University | Portland | Oregon | 97201 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00264810, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 28, 2013 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00264810 live on ClinicalTrials.gov.