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NCT04192591 · ClinicalTrials.gov registry record · NA
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
A NA study of Lumbar Spinal Stenosis, sponsored by Boston Scientific Corporation.
- Active
- Registry status
- NA
- Development phase
- 166
- Enrollment target
- 20
- Study locations
NCT04192591: Active NA study of Lumbar Spinal Stenosis, sponsored by Boston Scientific Corporation.
NCT04192591 is a NA study of Lumbar Spinal Stenosis that is active but no longer recruiting, run by Boston Scientific Corporation. The registered enrollment target is 166 participants, below the 660-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04192591, a NA study of Lumbar Spinal Stenosis, is active but no longer recruiting, sponsored by Boston Scientific Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 166 participants
- Enrollment target
- 20
- Study locations
Study Summary
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Primary Outcome
Non-inferiority of overall subject success at the 24-Month visit vs. the 24-month visit in IDE trial. An individual subject will be considered a success if they meet all of the following conditions at the 24-month follow-up visit: 1. Clinically significant improvement of neurogenic claudication symptoms as determined by meeting at least two of three domains of the ZCQ * ≥ 0.5-point improvement in physical function * ≥ 0.5-point improvement in symptom severity * ≤ 2.5 point on patient
Conditions Studied
Interventions
- DEVICE Superion™ IDS device
Study Locations (20)
California
- Coastal Research Institute, LLC - Carlsbad
- MarinHealth Spine Institute - Larkspur
- Vitamed Research - Rancho Mirage
- IPM Medical Group Inc. - Walnut Creek
Florida
- Holy Cross Hospital - Fort Lauderdale
- The Orthopaedic Institute - Gainesville
Georgia
- Alliance Spine and Pain Centers - Atlanta
- Centurion Spine and Pain - Waycross
Illinois
- Rush University Medical Center - Chicago
- Ascension Alexian Brothers - Elk Grove Village
Kansas
- University of Kansas Hospital - Kansas City
- Neuroscience Research Center, LLC - Overland Park
Idaho
- North Idaho Day Surgery - Post Falls
Massachusetts
- Brigham and Women's Hospital - Boston
Michigan
- Michigan Pain Specialists - Ypsilanti
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2020-01-30 |
| Est. Completion | 2041-02 |
| Phase | NA |
What the registry record for NCT04192591 still lists
NCT04192591 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 660-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Lumbar Spinal Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Superion™ IDS device is the first listed.
NCT04192591 names 20 study sites across 13 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04192591 about?
NCT04192591 is a clinical study titled "A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)". To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
What is the current status of trial NCT04192591?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 166 participants. The study started on 2020-01-30. Estimated completion is 2041-02.
What conditions does trial NCT04192591 study?
This clinical trial studies the following conditions: Lumbar Spinal Stenosis.
What interventions are being tested in trial NCT04192591?
The interventions under investigation include: Superion™ IDS device (DEVICE).
Who is sponsoring clinical trial NCT04192591?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04192591 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04192591's enrollment target sits among peer trials
166 6th of 18 higher than 13 of 18 other Lumbar Spinal Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lumbar Spinal Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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