Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-30 @ 9:09 PM
Study NCT ID:
NCT01486056
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2011-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECG Vector Determination
Sponsor:
Cyberonics, Inc.
Organization:
Study Overview
Official Title:
ECG Vector Determination for Model 106 Generator Implant Site Selection
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: