Trials / Terminated
TerminatedNCT01818297
Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients
SubQStim Pivotal Study: A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Nerve Stimulation. Protocol 1666
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 137 (actual)
- Sponsor
- MedtronicNeuro · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study is a multi-center, prospective, randomized (1:1) parallel-group design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PrimeAdvanced® neurostimulator system | Neurostimulator and associated components |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2013-03-26
- Last updated
- 2017-09-21
- Results posted
- 2017-09-21
Locations
27 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01818297. Inclusion in this directory is not an endorsement.