A Post Marketing Surveillance Study
NCT03366779 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-03-15
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.
Conditions
- Lumbar Disc Herniation
- Annular Disc Tear
- Annular Tear of Lumbar Disc
Interventions
- DEVICE
-
6mm annular closure device
6MM Barricaid annular closure device implantation following standard lumbar discectomy
Sponsors & Collaborators
-
Intrinsic Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-16
- Primary Completion
- 2024-06-30
- Completion
- 2024-12-31
Countries
- Belgium
- Germany
Study Locations
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