Trials / Completed
CompletedNCT00692276
Investigating Superion™ In Spinal Stenosis
A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) System in Patients With Moderate Lumbar Spinal Stenosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 391 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.
Detailed description
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. The study endpoint is the rate of overall subject success at 24 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Superion™ Interspinous Spacer | Implantation of interspinous process spacer to treat lumbar spinal stenosis |
| DEVICE | X-STOP® IPD® Device | Implantation of interspinous process spacer to treat lumbar spinal stenosis |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2017-02-01
- Completion
- 2017-02-01
- First posted
- 2008-06-06
- Last updated
- 2020-11-16
- Results posted
- 2020-08-25
Locations
32 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00692276. Inclusion in this directory is not an endorsement.