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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 is a NA study that has completed, run by Halyard Health. The registered enrollment target is 67 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01263054
The ClinicalTrials.gov registry entry for NCT01263054 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Halyard Health, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Medical Management is the first listed.
NCT01263054 reports 0 study locations.
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.
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