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NCT01878149 · ClinicalTrials.gov registry record
Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects
A clinical trial of Degenerative Disc Disease, sponsored by Baxano Surgical.
- Completed
- Registry status
- 34
- Enrollment target
- 4
- Study locations
NCT01878149: Completed study of Degenerative Disc Disease, sponsored by Baxano Surgical.
NCT01878149 is a study of Degenerative Disc Disease that has completed, run by Baxano Surgical. The registered enrollment target is 34 participants, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (80% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01878149, a study of Degenerative Disc Disease, has completed, sponsored by Baxano Surgical.
- COMPLETED
- Registry status
- 34 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this retrospective clinical evaluation is to compare VEO® single or multilevel results to XLIF® single or multilevel results relative to the safety endpoints. This study will collect retrospective data on subjects who were treated with VEO® and XLIF® at least 3 months prior to the initiation of this study. Given that fusion generally takes at least 6 months to determine, the aim of this study is not to determine fusion but to consider the short-term (out to 6 months) reported adverse events between the two cohorts. Devices used in both systems are cleared for use and conform to US regulatory requirements. The study employs these procedures and devices for uses that are consistent with their 510(k), legally cleared, labeling.
Primary Outcome
Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.
Conditions Studied
Study Locations (4)
California
- Memorial Orthopaedic Surgical Group - Long Beach
- Minimally Invasive Neurosurgery - Santa Ana
New York
- NorthShore LIJ - Great Neck
Virginia
- Advanced Spine & Pain - Arlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-03 |
What the finished NCT01878149 record still lists
NCT01878149 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Degenerative Disc Disease appearing as the primary indexed condition, and to 0 interventions.
NCT01878149 reports a single indexed study location in California, New York, Virginia.
Frequently Asked Questions
What is clinical trial NCT01878149 about?
NCT01878149 is a clinical study titled "Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects". The purpose of this retrospective clinical evaluation is to compare VEO® single or multilevel results to XLIF® single or multilevel results relative to the safety endpoints. This study will collect retrospective data on subjects who were treated with VEO® and XLIF® at least 3 months prior to the ini...
What is the current status of trial NCT01878149?
This trial is currently completed. The enrollment target is 34 participants. The study started on 2013-06. Estimated completion is 2014-03.
What conditions does trial NCT01878149 study?
This clinical trial studies the following conditions: Degenerative Disc Disease.
Who is sponsoring clinical trial NCT01878149?
This trial is sponsored by Baxano Surgical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01878149 being conducted?
This trial has 4 study locations across California, New York, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Degenerative Disc Disease
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Where NCT01878149's enrollment target sits among peer trials
34 38th of 42 higher than 5 of 42 other Degenerative Disc Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Degenerative Disc Disease 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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