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NCT01697358 · ClinicalTrials.gov registry record · Phase 4
Spinal Cord Stimulation for Predominant Low Back Pain
A Phase 4 study, sponsored by MedtronicNeuro.
- Completed
- Registry status
- Phase 4
- Development phase
- 278
- Enrollment target
NCT01697358 is a Phase 4 study that has completed, run by MedtronicNeuro. The registered enrollment target is 278 participants.
The verdict
NCT01697358, a Phase 4 study, has completed, sponsored by MedtronicNeuro.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 278 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).
Interventions
- DEVICE Spinal Cord Stimulation (SCS)
- DRUG Optimal Medical Management (OMM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2013-01-08 |
| Est. Completion | 2017-06-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01697358
The ClinicalTrials.gov registry entry for NCT01697358 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 278 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedtronicNeuro, which has 51 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Spinal Cord Stimulation (SCS) is the first listed.
NCT01697358 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01697358 about?
NCT01697358 is a clinical study titled "Spinal Cord Stimulation for Predominant Low Back Pain". The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBS...
What is the current status of trial NCT01697358?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 278 participants. The study started on 2013-01-08. Estimated completion is 2017-06-20.
What interventions are being tested in trial NCT01697358?
The interventions under investigation include: Spinal Cord Stimulation (SCS) (DEVICE), Optimal Medical Management (OMM) (DRUG).
Who is sponsoring clinical trial NCT01697358?
This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.
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