NCT01486056

ECG Vector Determination

ECG Vector Determination for Model 106 Generator Implant Site Selection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Cyberonics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data.

Detailed description

This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data and determine the process for proper generator and lead placement. The study will be conducted in two phases: Phase I includes ECG data collection from human subjects; Phase II, the Implant Instructions for Use will be evaluated by Cyberonics' Clinical Engineers based on the activities of five to eight experienced VNS surgeons.

Conditions

• Epilepsy

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-12-06
• Last updated: 2012-08-21

Locations

1 site across 1 country: United States