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A Post Marketing Surveillance Study — 6MM  

Lumbar Disc Herniation Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03366779
Study type Interventional
Source Intrinsic Therapeutics
Contact
Status Active, not recruiting
Phase Phase 4
Start date January 16, 2018
Completion date December 2024
View Details
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