NCT01846741

VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)

VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cyberonics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Detailed description

Prospective, observational, un-blinded, multi-site study designed to collect data on patients implanted with a Model 106 VNS Therapy System from baseline through an EMU stay of up to 5 days, and 6-month follow-up. After the 6-month follow-up, patients will continue follow-up for safety for approximately two years or until final regulatory approval of the product.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	M106 VNS Therapy System

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-08-01
• Completion: 2015-08-01
• First posted: 2013-05-03
• Last updated: 2015-11-24
• Results posted: 2015-07-14

Locations

15 sites across 1 country: United States