Trials / Completed
CompletedNCT04171544
Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up
Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up (OCT PMCF)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- RTI Surgical · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- —
Summary
This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.
Detailed description
This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System. The study will include a minimum of 58 patients at a minimum of 3 sites in the United States. The study will enroll at a minimum of 5 subjects implanted with the occipital plate.
Conditions
- Spinal Stenosis Occipito-Atlanto-Axial
- Spinal Disease
- Spinal Stenosis Cervical
- Spinal Stenosis Cervicothoracic Region
- Spinal Instability
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Streamline Occipito-Cervico-Thoracic Spinal Fixation System | Spinal Fixation |
Timeline
- Start date
- 2019-08-06
- Primary completion
- 2020-03-31
- Completion
- 2020-03-31
- First posted
- 2019-11-21
- Last updated
- 2020-10-27
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04171544. Inclusion in this directory is not an endorsement.