Trials / Completed
CompletedNCT02924129
Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation
A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke™ Spinal Cord Stimulator (SCS) System With Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- Saluda Medical Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Evoke Spinal Cord Stimulator (SCS) System | Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). |
Timeline
- Start date
- 2017-01-27
- Primary completion
- 2018-06-21
- Completion
- 2022-09-09
- First posted
- 2016-10-05
- Last updated
- 2024-01-03
- Results posted
- 2021-05-25
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02924129. Inclusion in this directory is not an endorsement.