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
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Australia
Interventus Pain Specialists
RECRUITING
Auchenflower
Sydney Pain Specialists
RECRUITING
Bella Vista
Axxon Pain Medicine
RECRUITING
Brisbane
Total Pain Clinic
RECRUITING
Brisbane
Genesis Research Services
RECRUITING
Broadmeadow
Northern Integrated Pain Management
RECRUITING
Charlestown
Monash Clinical Research
RECRUITING
Clayton
PainCare Perth
RECRUITING
Cottesloe
QPAIN
RECRUITING
Fortitude Valley
Frankston Pain Management
RECRUITING
Frankston
ACT Pain Centre
RECRUITING
Garran
Pain Matrix
RECRUITING
Geelong
Australian Medical Research
RECRUITING
Hurstville
Inner West Pain Centre
RECRUITING
Newtown
Sunshine Coast Clinical Research
RECRUITING
Noosa
Paul Frank Medical Services
RECRUITING
Peregian Beach
Melbourne Pain Specialists
RECRUITING
Richmond
Pain Specialists Australia
RECRUITING
Richmond
Royal North Shore Hospital
RECRUITING
Saint Leonards
Northern Pain Centre
RECRUITING
St Leonards
Women's Health & Research Institute of Australia
RECRUITING
Sydney
Sydney Pain Research Centre Pty Ltd
RECRUITING
Wahroonga
CerCare Pty Ltd
RECRUITING
Wayville
Contact Information
Primary
Director, Clinical Affairs
angela.leitner@saludamedical.com
16512084223
Time Frame
Start Date: 2020-12-15
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 200
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Saluda Medical Pty Ltd