Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01818297 · ClinicalTrials.gov registry record · NA
Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients
A NA study, sponsored by MedtronicNeuro.
- Terminated
- Registry status
- NA
- Development phase
- 137
- Enrollment target
NCT01818297: Clinical Trial NA study, sponsored by MedtronicNeuro.
NCT01818297 is a NA study that was terminated before completion, run by MedtronicNeuro. The registered enrollment target is 137 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01818297, a NA study, was terminated before completion, sponsored by MedtronicNeuro.
- TERMINATED
- Registry status
- NA
- Development phase
- 137 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation \[PNS\]) in the reduction of chronic, intractable post-surgical back pain in adults.
Primary Outcome
Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders.
Interventions
- DEVICE PrimeAdvanced® neurostimulator system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-03 |
| Phase | NA |
Why NCT01818297 stopped before completion
NCT01818297 is an interventional study that assigns participants to a tested intervention. The registered 137 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 (90% lower).
The record links to 0 conditions, and to 1 intervention - of which PrimeAdvanced® neurostimulator system is the first listed.
NCT01818297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01818297 about?
NCT01818297 is a clinical study titled "Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients". The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation \[PNS\]) in the reduction of chronic, intractable post-surgical back pain in adults.
What is the current status of trial NCT01818297?
This trial is currently terminated. It is a NA study. The enrollment target is 137 participants. The study started on 2013-04. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01818297?
The interventions under investigation include: PrimeAdvanced® neurostimulator system (DEVICE).
Who is sponsoring clinical trial NCT01818297?
This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01818297's enrollment target sits among peer trials
137 722nd of 2000 higher than 1,279 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05091424 · 137 participants · Phase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
- NCT05655182 · 137 participants · Phase 1
A Study of BLB-201 RSV Vaccine in Infants and Children
- NCT06571669 · 137 participants · NA
BOOM-IBD2 Pivotal Clinical Trial
- NCT06644768 · 137 participants · Phase 1
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia