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NCT01036529 · ClinicalTrials.gov registry record · Phase 4
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
A Phase 4 study, sponsored by Boston Scientific Corporation.
- Terminated
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT01036529 is a Phase 4 study that was terminated before completion, run by Boston Scientific Corporation. The registered enrollment target is 28 participants.
The verdict
NCT01036529, a Phase 4 study, was terminated before completion, sponsored by Boston Scientific Corporation.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as persistent or recurrent pain following one or more lumbosacral spine surgical procedures. Surgical procedures that can result in FBSS can be categorized as either decompression or decompression followed by fusion with or without instrumentation. The pain of FBSS is categorized as neuropathic, which involves pathological nerve activity and is commonly characterized by patients as shooting or burning and/or nociceptive, which signals actual or impending tissue damage or inflammation.
Interventions
- DEVICE Precision Spinal Cord Stimulator
- PROCEDURE Back Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-02 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01036529
The ClinicalTrials.gov registry entry for NCT01036529 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Precision Spinal Cord Stimulator is the first listed.
NCT01036529 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01036529 about?
NCT01036529 is a clinical study titled "Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome". The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as persistent or recurren...
What is the current status of trial NCT01036529?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2010-02. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01036529?
The interventions under investigation include: Precision Spinal Cord Stimulator (DEVICE), Back Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT01036529?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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