New method for delivering spinal cord stimulation for chronic pain relief

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

This study is testing a new spinal cord stimulation system to see if it can help people with chronic pain feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Saluda Medical Pty Ltd (Industry-sponsored)
• Locations: 23 sites (Garran, Australian Capital Territory and 22 other locations)
• Trial ID: NCT04662905 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel approach to spinal cord stimulation (SCS) using the Evoke System, which incorporates advanced software and hardware features for better pain management. Participants will either have undergone a trial implant or are planning to be implanted with the Evoke System. The study aims to assess the effectiveness of this ECAP-controlled closed-loop SCS in providing relief for chronic pain patients.

Who should consider this trial

Good fit: Ideal candidates include individuals who are candidates for the Evoke System and have chronic pain.

Not a fit: Patients who do not qualify for the Evoke System or are not experiencing chronic pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve pain management for patients suffering from chronic pain.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in the field of spinal cord stimulation, suggesting potential for success.

Eligibility criteria

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

Where this trial is running

Garran, Australian Capital Territory and 22 other locations

• ACT Pain Centre — Garran, Australian Capital Territory, Australia (Recruiting)
• Sydney Pain Specialists — Bella Vista, New South Wales, Australia (Recruiting)
• Genesis Research Services — Broadmeadow, New South Wales, Australia (Recruiting)
• Northern Integrated Pain Management — Charlestown, New South Wales, Australia (Recruiting)
• Australian Medical Research — Hurstville, New South Wales, Australia (Recruiting)
• Inner West Pain Centre — Newtown, New South Wales, Australia (Recruiting)
• Royal North Shore Hospital — Saint Leonards, New South Wales, Australia (Recruiting)
• Northern Pain Centre — St Leonards, New South Wales, Australia (Recruiting)
• Women's Health & Research Institute of Australia — Sydney, New South Wales, Australia (Recruiting)
• Sydney Pain Research Centre Pty Ltd — Wahroonga, New South Wales, Australia (Recruiting)
• Interventus Pain Specialists — Auchenflower, Queensland, Australia (Recruiting)
• Axxon Pain Medicine — Brisbane, Queensland, Australia (Recruiting)
• Total Pain Clinic — Brisbane, Queensland, Australia (Recruiting)
• Qpain — Fortitude Valley, Queensland, Australia (Recruiting)
• Sunshine Coast Clinical Research — Noosa, Queensland, Australia (Recruiting)
• Paul Frank Medical Services — Peregian Beach, Queensland, Australia (Recruiting)
• CerCare Pty Ltd — Wayville, South Australia, Australia (Recruiting)
• Monash Clinical Research — Clayton, Victoria, Australia (Recruiting)
• Frankston Pain Management — Frankston, Victoria, Australia (Recruiting)
• Pain Matrix — Geelong, Victoria, Australia (Recruiting)
• Melbourne Pain Specialists — Richmond, Victoria, Australia (Recruiting)
• Pain Specialists Australia — Richmond, Victoria, Australia (Recruiting)
• PainCare Perth — Cottesloe, Western Australia, Australia (Recruiting)

Study contacts

• Study coordinator: Director, Clinical Affairs

Conditions Chronic Pain