Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00205868
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2005-09-13
Brief Title:
Spinal Cord Stimulation for Low Back Pain
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain
Status:
COMPLETED
Status Verified Date:
2021-05
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 study is to assess the acute and chronic effectiveness of the Advanced Bionics PrecisionTM Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain
Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy
Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None