RecruitingNot ApplicableNCT04662905

Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain

A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs


Sponsor

Saluda Medical Pty Ltd

Enrollment

200 participants

Start Date

Dec 15, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • \. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.
  • \. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.

Exclusion Criteria1

  • N/A

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Interventions

DEVICEEvoke Spinal Cord Stimulation (SCS) System

ECAP-controlled, closed-loop SCS


Locations(23)

ACT Pain Centre

Garran, Australian Capital Territory, Australia

Sydney Pain Specialists

Bella Vista, New South Wales, Australia

Genesis Research Services

Broadmeadow, New South Wales, Australia

Northern Integrated Pain Management

Charlestown, New South Wales, Australia

Australian Medical Research

Hurstville, New South Wales, Australia

Inner West Pain Centre

Newtown, New South Wales, Australia

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Northern Pain Centre

St Leonards, New South Wales, Australia

Women's Health & Research Institute of Australia

Sydney, New South Wales, Australia

Sydney Pain Research Centre Pty Ltd

Wahroonga, New South Wales, Australia

Interventus Pain Specialists

Auchenflower, Queensland, Australia

Axxon Pain Medicine

Brisbane, Queensland, Australia

Total Pain Clinic

Brisbane, Queensland, Australia

QPAIN

Fortitude Valley, Queensland, Australia

Sunshine Coast Clinical Research

Noosa, Queensland, Australia

Paul Frank Medical Services

Peregian Beach, Queensland, Australia

CerCare Pty Ltd

Wayville, South Australia, Australia

Monash Clinical Research

Clayton, Victoria, Australia

Frankston Pain Management

Frankston, Victoria, Australia

Pain Matrix

Geelong, Victoria, Australia

Melbourne Pain Specialists

Richmond, Victoria, Australia

Pain Specialists Australia

Richmond, Victoria, Australia

PainCare Perth

Cottesloe, Western Australia, Australia

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NCT04662905


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