EVA: Evaluation of EVOKE Therapy Metrics Generated Using the Evoke System With EVA

NCT ID: NCT07267715

Last Updated: 2025-12-05

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-11-01

Brief Summary

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The Evoke Spinal Cord Stimulator (SCS) System (Evoke® System) is an FDA-approved device that is used to manage long lasting, severe pain that is not relieved by typical medical treatments.

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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is not pregnant and 18 years of age or older at the time of enrollment.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saluda Medical Pty Ltd

INDUSTRY

Sponsor Role collaborator

Dustin Reynolds, MD

OTHER

Sponsor Role lead

Responsible Party

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Dustin Reynolds, MD

Interventional Pain Management Specialist, Anesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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United States

Central Contacts

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Melissa B. Showe

Role: CONTACT

1-614-775-6607

Facility Contacts

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Cameron Rink, PhD, MBA

Role: primary

614-546-4518

Other Identifiers

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250714-1

Identifier Type: -

Identifier Source: org_study_id

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