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NCT00205868 · ClinicalTrials.gov registry record · Phase 4
Spinal Cord Stimulation for Low Back Pain
A Phase 4 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 4
- Development phase
- 304
- Enrollment target
NCT00205868: Completed Phase 4 study, sponsored by Boston Scientific Corporation.
NCT00205868 is a Phase 4 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 304 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00205868, a Phase 4 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 304 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the acute and chronic effectiveness of the Advanced Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain. Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
Primary Outcome
Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Interventions
- DEVICE Precision Spinal Cord Stimulation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2004-12 |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
What the finished NCT00205868 record still lists
NCT00205868 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 1 intervention - of which Precision Spinal Cord Stimulation System is the first listed.
NCT00205868 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00205868 about?
NCT00205868 is a clinical study titled "Spinal Cord Stimulation for Low Back Pain". The purpose of this study is to assess the acute and chronic effectiveness of the Advanced Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain. Subjects will undergo a temporary or permanent trial to assess their cand...
What is the current status of trial NCT00205868?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 304 participants. The study started on 2004-12. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00205868?
The interventions under investigation include: Precision Spinal Cord Stimulation System (DEVICE).
Who is sponsoring clinical trial NCT00205868?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00205868's enrollment target sits among peer trials
304 264th of 2000 higher than 1,735 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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