Trials / Active Not Recruiting
Active Not RecruitingNCT06246526
Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Saint Francis Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Evoke | The Saluda Medical Evoke® CL-SCS System (Evoke System). The Evoke System measures and records spinal cord (SC) activation resulting from stimulation via evoked compound action potentials (ECAPs). The Evoke System can be programmed to provide ECAP-controlled, closed-loop SCS or open-loop, fixed-output (traditional) SCS; ECAPs may be measured and recorded in either stimulation mode. |
Timeline
- Start date
- 2024-01-30
- Primary completion
- 2025-09-30
- Completion
- 2026-12-31
- First posted
- 2024-02-07
- Last updated
- 2025-10-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06246526. Inclusion in this directory is not an endorsement.