Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 8:35 AM
Study NCT ID:
NCT01050959
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2010-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Compassionate Use Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches
Status:
COMPLETED
Status Verified Date:
2013-11
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:
The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief of headache symptoms that have not responded to medical treatment. These study subjects were enrolled and implanted with the Bion® system during a previous clinical investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| G030225/S022 | OTHER | FDA | View |