Trials / Active Not Recruiting
Active Not RecruitingNCT04192591
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 166 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Detailed description
To compile real-world outcomes of the Superion™ IDS in routine clinical practice, when used according to the applicable Directions for Use
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Superion™ IDS device | The Superion™ IDS is a minimally-invasive spinal implant that treats LSS symptoms by limiting extension at the symptomatic level that compresses the neural elements and is designed for percutaneous surgical placement. |
Timeline
- Start date
- 2020-01-30
- Primary completion
- 2038-02-01
- Completion
- 2041-02-01
- First posted
- 2019-12-10
- Last updated
- 2026-04-03
Locations
23 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04192591. Inclusion in this directory is not an endorsement.