Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).

Part of paid clinical trials in Charleston, West Virginia.

Sponsor
Saint Francis Hospital
Study ID
NCT06246526
Status
Recruiting
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Conditions

  • Chronic Pain
  • Neuropathic Pain
  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evoke — DEVICE
    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.

Study Details

This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.

Key Dates

Start date
Jan 30, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

VAS - Visual Analog Scale [ Time Frame: Baseline to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Spine and Nerve Center of Saint Francis HospitalCharlestonWest Virginia25301
Amy Young, RN BSN DMPNA
[email protected]
3043476144

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By research site
The Spine and Nerve Center of Saint Francis Hospital· Charleston, WV

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