ECG Vector Determination
This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||ECG Vector Determination for Model 106 Generator Implant Site Selection|
- To correlate ECG amplitude with prospective VNS implant sites. [ Time Frame: up to 2 days ] [ Designated as safety issue: No ]This study is designed to collect ECG data to determine the process for proper generator and lead placement.
- To identify potential VNS implant sites associated with low ECG amplitudes. [ Time Frame: up to 2 days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
healthy patients, may have epilepsy
Subjects at least 12 years old and in general good health for Phase I, and at least 18 years old and in general good health for Phase II. It is desired, but not required, for subjects to have epilepsy and taking at least 1 antiepileptic medication.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486056
|United States, Texas|
|Clinical Trials of Texas, Inc.|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Douglas Denham, DO||Clinical Trails of Texas, Inc.|
|Study Director:||Bryan Olin, Ph.D||Cyberonics, Inc.|