Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03366779
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2017-11-28
Brief Title:
A Post Marketing Surveillance Study
Sponsor:
Intrinsic Therapeutics
Organization:
Intrinsic Therapeutics
Study Overview
Official Title:
A Post Marketing Surveillance Study To Monitor The Early Safety And Performance Of The BARRICAID Anular Closure Device In The Treatment Of Radicular Pain Caused By Primary Lumbar Disc Herniation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
6MM
Brief Summary:
This study is a prospective multi-center study to monitor the early safety and performance of one iteration of the Barricaid Anular Closure Device ACD - 6mm anchor width when used as an adjunct to limited discectomy
Detailed Description:
This study is planned to collect information on use of the Barricaid ACD with an anchor width of 6mm Other iterations of the device are made with an 8mm wide anchor The narrower anchor was designed to optimize surgeon visualization during implantation and has undergone all appropriate rigorous testing prior to release Safety will be evaluated to demonstrate acceptable levels of device-related and procedure-related complications This limited market release will allow its performance to be evaluated by examining the effects on reoperation device deficiencies patient pain scores and disability after discectomy with ACD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None