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NCT00079781 · ClinicalTrials.gov registry record · Phase 2
RNS® System Feasibility Study
A Phase 2 study, sponsored by NeuroPace.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT00079781: Completed Phase 2 study, sponsored by NeuroPace.
NCT00079781 is a Phase 2 study that has completed, run by NeuroPace. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00079781, a Phase 2 study, has completed, sponsored by NeuroPace.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
The RNS® System is intended to treat patients with medically refractory (hard to treat) epilepsy. The RNS® System Feasibility study is designed to demonstrate safety and evidence of effectiveness of the RNS® System to support the commencement of a pivotal clinical investigation.
Primary Outcome
RNS® System Acute SAE Rate = the percentage of subjects having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not. This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial
Interventions
- PROCEDURE RNS® System implantation
- DEVICE RNS® System responsive stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2004-01 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
What the finished NCT00079781 record still lists
NCT00079781 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which RNS® System implantation is the first listed.
NCT00079781 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00079781 about?
NCT00079781 is a clinical study titled "RNS® System Feasibility Study". The RNS® System is intended to treat patients with medically refractory (hard to treat) epilepsy. The RNS® System Feasibility study is designed to demonstrate safety and evidence of effectiveness of the RNS® System to support the commencement of a pivotal clinical investigation.
What is the current status of trial NCT00079781?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2004-01. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00079781?
The interventions under investigation include: RNS® System implantation (PROCEDURE), RNS® System responsive stimulation (DEVICE).
Who is sponsoring clinical trial NCT00079781?
This trial is sponsored by NeuroPace, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00079781's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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