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NCT01923285 · ClinicalTrials.gov registry record · NA
A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 152
- Enrollment target
NCT01923285: Completed NA study, sponsored by Abbott Medical Devices.
NCT01923285 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 152 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01923285, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 152 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).
Primary Outcome
Treatment Success is defined as at least 50% lower limb pain relief (VAS score reduction) at the end of trial phase, received at least 50% lower limb pain relief at the 3-month visit post implant, and the absence of a stimulation related neurological deficit. Pain scores were measured using Visual Analog Scale (VAS). The VAS score ranges from 0-100 mm with a higher score indicating higher pain intensity ( 0 representing "No Pain" and 100 mm representing "Worst Imaginable Pain").
Interventions
- DEVICE AXIUM Neurostimulator System
- DEVICE Control Spinal Cord Stimulation Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-09 |
| Phase | NA |
What the finished NCT01923285 record still lists
NCT01923285 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which AXIUM Neurostimulator System is the first listed.
NCT01923285 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01923285 about?
NCT01923285 is a clinical study titled "A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain". The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).
What is the current status of trial NCT01923285?
This trial is currently completed. It is a NA study. The enrollment target is 152 participants. The study started on 2013-08. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01923285?
The interventions under investigation include: AXIUM Neurostimulator System (DEVICE), Control Spinal Cord Stimulation Device (DEVICE).
Who is sponsoring clinical trial NCT01923285?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01923285's enrollment target sits among peer trials
152 658th of 2000 higher than 1,340 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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