Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-03-01 @ 8:57 PM
Study NCT ID:
NCT00533832
Status:
COMPLETED
Last Update Posted:
2007-09-24
First Post:
2007-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pivotal Trial (D02) of Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD)
Sponsor:
Cyberonics, Inc.
Organization:
Study Overview
Official Title:
A Multicernter, Pivotal, Safety and Efficacy Study of the NeuroCtybernetic Prosthesis (NCP(R)) System in Patients With Depression
Status:
COMPLETED
Status Verified Date:
2007-09
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:
To confirm the safety and efficacy of the NCP System in treating patients in a nmajor depressive episode.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: