NCT03366779

A Post Marketing Surveillance Study

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: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Intrinsic Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Disc Herniation
• Annular Disc Tear
• Annular Tear of Lumbar Disc

Interventions

Type	Name	Description
DEVICE	6mm annular closure device	6MM Barricaid annular closure device implantation following standard lumbar discectomy

Timeline

• Start date: 2018-01-16
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2017-12-08
• Last updated: 2024-03-15

Locations

2 sites across 2 countries: Belgium, Germany