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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Evoke Spinal Cord Stimulation (SCS) System

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Director, Clinical Affairs; Phone Number: 16512084223; Email: angela.leitner@saludamedical.com

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Recruiting
      • ACT Pain Centre
  • New South Wales
    • Bella Vista, New South Wales, Australia, 2153
      • Recruiting
      • Sydney Pain Specialists
    • Broadmeadow, New South Wales, Australia, 2292
      • Recruiting
      • Genesis Research Services
    • Charlestown, New South Wales, Australia, 2290
      • Recruiting
      • Northern Integrated Pain Management
    • Hurstville, New South Wales, Australia, 2220
      • Recruiting
      • Australian Medical Research
    • Newtown, New South Wales, Australia, 2042
      • Recruiting
      • Inner West Pain Centre
    • Saint Leonards, New South Wales, Australia, 2065
      • Recruiting
      • Royal North Shore Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Recruiting
      • Northern Pain Centre
    • Sydney, New South Wales, Australia, 2000
      • Recruiting
      • Women's Health & Research Institute of Australia
    • Wahroonga, New South Wales, Australia, 2076
      • Recruiting
      • Sydney Pain Research Centre Pty Ltd
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Recruiting
      • Interventus Pain Specialists
    • Brisbane, Queensland, Australia, 4000
      • Recruiting
      • Axxon Pain Medicine
    • Fortitude Valley, Queensland, Australia, 4006
      • Recruiting
      • QPAIN
    • Noosa Heads, Queensland, Australia, 4567
      • Recruiting
      • Sunshine Coast Clinical Research
    • Peregian Beach, Queensland, Australia, 4573
      • Recruiting
      • Paul Frank Medical Services
  • South Australia
    • Wayville, South Australia, Australia, 5034
      • Recruiting
      • CerCare Pty Ltd
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Clinical Research
    • Frankston, Victoria, Australia, 3199
      • Recruiting
      • Frankston Pain Management
    • Geelong, Victoria, Australia, 3220
      • Recruiting
      • Pain Matrix
    • Richmond, Victoria, Australia, 3121
      • Recruiting
      • Melbourne Pain Specialists
    • Richmond, Victoria, Australia, 3121
      • Recruiting
      • Pain Specialists Australia
  • Western Australia
    • Cottesloe, Western Australia, Australia, 6011
      • Recruiting
      • PainCare Perth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Evoke Spinal Cord Stimulation (SCS) System; ECAP-controlled, closed-loop SCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System	Through study completion, up to 2 years

Collaborators and Investigators

• Sponsor: Saluda Medical Pty Ltd
• Investigators: Study Director: Angela M Leitner, Saluda Medical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: CLIN-PCL-007873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No