Trials / Unknown
UnknownNCT05467072
PMCFU of an Annular Closure System
Post-Marketing Clinical Follow-up of an Annular Closure System
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (estimated)
- Sponsor
- Intrinsic Therapeutics · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this retrospective chart review study is to collect the data that will be used to provide clinical evidence to support the post-market surveillance program.
Detailed description
Retrospective chart review of patients treated with lumbar discectomy and annular closure. Review of patient charts through 3 month post op, for analysis of symptomatic lumbar reherniation at the index level.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Annular closure | Lumbar discectomy patients treated with Annular Closure Device BARRICAID |
Timeline
- Start date
- 2023-09-27
- Primary completion
- 2024-10-01
- Completion
- 2025-10-01
- First posted
- 2022-07-20
- Last updated
- 2023-09-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05467072. Inclusion in this directory is not an endorsement.