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NCT01263054 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain
A NA study, sponsored by Halyard Health.
- Completed
- Registry status
- NA
- Development phase
- 67
- Enrollment target
NCT01263054: Completed NA study, sponsored by Halyard Health.
NCT01263054 is a NA study that has completed, run by Halyard Health. The registered enrollment target is 67 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01263054, a NA study, has completed, sponsored by Halyard Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 67 participants
- Enrollment target
Study Summary
The primary objective of this randomized controlled trial is to evaluate the safety and efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure. The primary efficacy measure will be the Visual Analog Scale (VAS) at 6 months post treatment/randomization and the TransDiscal System will be compared against medical management (standard of care).
Primary Outcome
Visual Analog Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
Interventions
- OTHER Medical Management
- DEVICE TransDiscal System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2010-12 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT01263054 record still lists
NCT01263054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Medical Management is the first listed.
NCT01263054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01263054 about?
NCT01263054 is a clinical study titled "Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain". The primary objective of this randomized controlled trial is to evaluate the safety and efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure. The primary efficacy measure will be the Visual Analog Scale (VAS) at 6 months...
What is the current status of trial NCT01263054?
This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2010-12. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01263054?
The interventions under investigation include: Medical Management (OTHER), TransDiscal System (DEVICE).
Who is sponsoring clinical trial NCT01263054?
This trial is sponsored by Halyard Health, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01263054's enrollment target sits among peer trials
67 1139th of 2000 higher than 862 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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