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NCT00697827 · ClinicalTrials.gov registry record · Phase 3
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
A Phase 3 study, sponsored by Synthes USA HQ.
- Terminated
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT00697827: Clinical Trial Phase 3 study, sponsored by Synthes USA HQ.
NCT00697827 is a Phase 3 study that was terminated before completion, run by Synthes USA HQ. The registered enrollment target is 44 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00697827, a Phase 3 study, was terminated before completion, sponsored by Synthes USA HQ.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.
Primary Outcome
The questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction. The scale relates to symptoms over the past month. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability. An individual patient treatment will be considered a success if they meet at least two of three components defined as an improvement of ≥ 0.5 as compared to preoperative score for the symptom severity and physical fun
Interventions
- DEVICE Interspinous Spacer device
- DEVICE Interspinous Process Distraction Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2008-06 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
Why NCT00697827 stopped before completion
NCT00697827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Interspinous Spacer device is the first listed.
NCT00697827 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00697827 about?
NCT00697827 is a clinical study titled "A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis". The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at ...
What is the current status of trial NCT00697827?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2008-06. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00697827?
The interventions under investigation include: Interspinous Spacer device (DEVICE), Interspinous Process Distraction Device (DEVICE).
Who is sponsoring clinical trial NCT00697827?
This trial is sponsored by Synthes USA HQ, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00697827's enrollment target sits among peer trials
44 1874th of 2000 higher than 125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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