EVA: Evaluation of EVOKE Therapy Metrics Generated Using the Evoke System With EVA
NCT ID: NCT07267715
Last Updated: 2025-12-05
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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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2025-11-30
2026-11-01
Brief Summary
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This research registry is being conducted to collect data from patients treated with a SCS device in order to determine how the device impacts their chronic pain condition.
Specifically, the study aims to:
* Evaluate data collected from the SCS system on how well the system is working.
* Evaluate the feasibility of programming the SCS system independently without external assistance.
* Evaluate changes in physical function, fatigue, pain interference, mood, sleep, daily activities, pain control, and overall satisfaction with the device.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SCS Evoke System Implant
Subjects with chronic, intractable focal pain of the trunk and/or limbs who undergo Evoke System implant.
Spinal Cord Stimulation (SCS) System
Spinal cord stimulation system as an aid in the management of chronic intractable pain of the trunk and/or limbs; and will be used within its commercially approved indication.
Interventions
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Spinal Cord Stimulation (SCS) System
Spinal cord stimulation system as an aid in the management of chronic intractable pain of the trunk and/or limbs; and will be used within its commercially approved indication.
Eligibility Criteria
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Inclusion Criteria
* Subject has a minimum NRS score of 6 or higher (where 10 indicates the worst imaginable pain) in primary area of pain at baseline.
* Subject is planning to have a temporary trial with the Evoke® System to aid in the management of chronic intractable pain of the trunk and/or limbs.
* Subject is willing to program the Evoke® System using EVA™ under the supervision of the study investigator or Qualified Health Professional.
* Subject is being trialed with a neurostimulation system for the first time.
* Subject is able to read and understand English.
* Subject is capable of subjective evaluation; subject must be able to describe and rate his/her pain levels.
* Subject is willing and capable of giving informed consent.
* Subject is willing and able to comply with study-related requirements, procedures, and visits.
* Subject has adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator.
18 Years
ALL
No
Sponsors
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Saluda Medical Pty Ltd
INDUSTRY
Dustin Reynolds, MD
OTHER
Responsible Party
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Dustin Reynolds, MD
Interventional Pain Management Specialist, Anesthesiologist
Principal Investigators
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Dustin Reynolds, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Carmel Health System
Locations
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Mount Carmel Health System
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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250714-1
Identifier Type: -
Identifier Source: org_study_id
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