Trials / Completed
CompletedNCT04563793
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 129 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Detailed description
The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Superion™ IDS | All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms. |
Timeline
- Start date
- 2020-10-08
- Primary completion
- 2023-03-20
- Completion
- 2023-03-20
- First posted
- 2020-09-24
- Last updated
- 2025-01-13
- Results posted
- 2025-01-13
Locations
23 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04563793. Inclusion in this directory is not an endorsement.