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NCT01846741 · ClinicalTrials.gov registry record · NA
VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)
A NA study of Epilepsy, sponsored by Cyberonics.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 15
- Study locations
NCT01846741: Completed NA study of Epilepsy, sponsored by Cyberonics.
NCT01846741 is a NA study of Epilepsy that has completed, run by Cyberonics. The registered enrollment target is 20 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (98% lower). The trial reports 15 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01846741, a NA study of Epilepsy, has completed, sponsored by Cyberonics.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 15
- Study locations
Study Summary
Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator
Primary Outcome
The purpose for determining the effect size was to power a stage 2 study. At the conclusion of stage 1 of the E-37 study, it was determined that another study would not be necessary as it would not provide incremental clinical benefit information above what has already been collected. Therefore, computation of effect size was not necessary.
Conditions Studied
Interventions
- DEVICE M106 VNS Therapy System
Study Locations (15)
Texas
- - Dallas
- - Houston
Arizona
- - Phoenix
California
- - Stanford
Florida
- - Tampa
Georgia
- - Atlanta
Illinois
- - Chicago
Michigan
- - Ann Arbor
Minnesota
- - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-08 |
| Phase | NA |
What the finished NCT01846741 record still lists
NCT01846741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which M106 VNS Therapy System is the first listed.
NCT01846741 lists 15 locations in 14 states (Texas, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT01846741 about?
NCT01846741 is a clinical study titled "VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)". Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator
What is the current status of trial NCT01846741?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2013-07. Estimated completion is 2015-08.
What conditions does trial NCT01846741 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT01846741?
The interventions under investigation include: M106 VNS Therapy System (DEVICE).
Who is sponsoring clinical trial NCT01846741?
This trial is sponsored by Cyberonics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01846741 being conducted?
This trial has 15 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01846741's enrollment target sits among peer trials
20 131st of 160 higher than 24 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy 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.
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