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

Not Applicable

Recruiting

• Conditions: Chronic Pain

• Registration Number: NCT04662905
• Lead Sponsor: Saluda Medical Pty Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-10
• Study Start: 2020-12-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

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

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