Trials / Completed
CompletedNCT04319887
ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)
A Prospective, Multicenter, Single-arm Study Examining ECAP-controlled, Closed-loop Stimulation With the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Saluda Medical Pty Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Evoke Spinal Cord Stimulation (SCS) System | A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude |
Timeline
- Start date
- 2020-10-29
- Primary completion
- 2023-12-28
- Completion
- 2023-12-28
- First posted
- 2020-03-24
- Last updated
- 2024-12-31
- Results posted
- 2024-12-31
Locations
22 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04319887. Inclusion in this directory is not an endorsement.