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NCT01156675 · ClinicalTrials.gov registry record · NA
Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer
A NA study, sponsored by Globus Medical.
- Terminated
- Registry status
- NA
- Development phase
- 215
- Enrollment target
NCT01156675: Clinical Trial NA study, sponsored by Globus Medical.
NCT01156675 is a NA study that was terminated before completion, run by Globus Medical. The registered enrollment target is 215 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01156675, a NA study, was terminated before completion, sponsored by Globus Medical.
- TERMINATED
- Registry status
- NA
- Development phase
- 215 participants
- Enrollment target
Study Summary
The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one or two contiguous levels.
Primary Outcome
Change in the Zurich Claudication Questionnaire (ZCQ) score at 24 months compared with the score at baseline as follows: * Change of \>0.5 points in Physical Function on a scale of 1-4 points (lower values are considered a better outcome) * Change of \>0.5 points in Symptom Severity on a scale of 1-5 points (lower values are considered a better outcome) * Satisfaction of \<2.5 points on a scale of 1-4 points (lower values are considered a better outcome) The Zurich Claudication Questionnaire is
Interventions
- DEVICE FLEXUS(TM) Interspinous Spacer
- DEVICE XSTOP® Interspinous Spacer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2008-06 |
| Est. Completion | 2015-07 |
| Phase | NA |
Why NCT01156675 stopped before completion
NCT01156675 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which FLEXUS(TM) Interspinous Spacer is the first listed.
NCT01156675 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01156675 about?
NCT01156675 is a clinical study titled "Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer". The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one or two contiguous levels.
What is the current status of trial NCT01156675?
This trial is currently terminated. It is a NA study. The enrollment target is 215 participants. The study started on 2008-06. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01156675?
The interventions under investigation include: FLEXUS(TM) Interspinous Spacer (DEVICE), XSTOP® Interspinous Spacer (DEVICE).
Who is sponsoring clinical trial NCT01156675?
This trial is sponsored by Globus Medical, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01156675's enrollment target sits among peer trials
215 487th of 2000 higher than 1,514 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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