Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).
Saint Francis Hospital
50 participants
Jan 30, 2024
INTERVENTIONAL
Conditions
Summary
This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.
Eligibility
Inclusion Criteria6
- Be 18 years of age or older at the time of enrollment.
- Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
- Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline.
- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
- Be willing and capable of giving informed consent.
- Be willing and able to comply with study-related requirements, procedures, and visits.
Exclusion Criteria6
- Subject is pregnant or nursing.
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.
- Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
- Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
- Have prior experience with SCS.
- Be concomitantly participating in another clinical study.
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Interventions
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.
Locations(1)
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NCT06246526