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

NCT ID: NCT04662905

Last Updated: 2025-05-13

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

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ECAP-controlled, closed-loop SCS

Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Group Type EXPERIMENTAL

Evoke Spinal Cord Stimulation (SCS) System

Intervention Type DEVICE

ECAP-controlled, closed-loop SCS

Interventions

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Evoke Spinal Cord Stimulation (SCS) System

ECAP-controlled, closed-loop SCS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saluda Medical Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela M Leitner

Role: STUDY_DIRECTOR

Saluda Medical Pty Ltd

Locations

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ACT Pain Centre

Garran, Australian Capital Territory, Australia

Site Status RECRUITING

Sydney Pain Specialists

Bella Vista, New South Wales, Australia

Site Status RECRUITING

Genesis Research Services

Broadmeadow, New South Wales, Australia

Site Status RECRUITING

Northern Integrated Pain Management

Charlestown, New South Wales, Australia

Site Status RECRUITING

Australian Medical Research

Hurstville, New South Wales, Australia

Site Status RECRUITING

Inner West Pain Centre

Newtown, New South Wales, Australia

Site Status RECRUITING

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Site Status RECRUITING

Northern Pain Centre

St Leonards, New South Wales, Australia

Site Status RECRUITING

Women's Health & Research Institute of Australia

Sydney, New South Wales, Australia

Site Status RECRUITING

Sydney Pain Research Centre Pty Ltd

Wahroonga, New South Wales, Australia

Site Status RECRUITING

Interventus Pain Specialists

Auchenflower, Queensland, Australia

Site Status RECRUITING

Axxon Pain Medicine

Brisbane, Queensland, Australia

Site Status RECRUITING

Total Pain Clinic

Brisbane, Queensland, Australia

Site Status RECRUITING

QPAIN

Fortitude Valley, Queensland, Australia

Site Status RECRUITING

Sunshine Coast Clinical Research

Noosa, Queensland, Australia

Site Status RECRUITING

Paul Frank Medical Services

Peregian Beach, Queensland, Australia

Site Status RECRUITING

CerCare Pty Ltd

Wayville, South Australia, Australia

Site Status RECRUITING

Monash Clinical Research

Clayton, Victoria, Australia

Site Status RECRUITING

Frankston Pain Management

Frankston, Victoria, Australia

Site Status RECRUITING

Pain Matrix

Geelong, Victoria, Australia

Site Status RECRUITING

Melbourne Pain Specialists

Richmond, Victoria, Australia

Site Status RECRUITING

Pain Specialists Australia

Richmond, Victoria, Australia

Site Status RECRUITING

PainCare Perth

Cottesloe, Western Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Director, Clinical Affairs

Role: CONTACT

16512084223

Other Identifiers

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CLIN-PCL-007873

Identifier Type: -

Identifier Source: org_study_id

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