Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).
NCT ID: NCT06246526
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
25 participants
INTERVENTIONAL
2024-01-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 Criteria
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.
18 Years
ALL
No
Sponsors
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Saluda Medical Americas, Inc.
INDUSTRY
Saint Francis Hospital
OTHER
Responsible Party
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Principal Investigators
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Timothy Deer, MD
Role: PRINCIPAL_INVESTIGATOR
Spine and Nerve Center of Saint Francis Hospital
Locations
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The Spine and Nerve Center of Saint Francis Hospital
Charleston, West Virginia, United States
Countries
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Other Identifiers
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ULTRA Protocol 1.0
Identifier Type: -
Identifier Source: org_study_id
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