Prospective data collection to evaluate the feedback control of the Saluda Medical's EvokeTM Spinal Cord Stimulation System in the treatment of patients with chronic pain of the trunk and/or limbs.
Recruiting
- Conditions
- Chronic pain in the trunk and/or limbs
- Registration Number
- NL-OMON29510
- Lead Sponsor
- Saluda Medical
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Male and female subjects
Age 18 and older
Suffering from chronic pain in trunk and/or limbs
Routinely scheduled for SCS with Saluda Medical System
Subject approval for prospective data collection and transfer of de-identified data to Saluda Medical
Exclusion Criteria
No exclusion criteria
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Collection of electrophysiological and device data from the EvokeTM Closed-Loop SCS system in the treatment of chronic pain of trunk and/or limbs, in a 'real world' setting under normal clinical use.
- Secondary Outcome Measures
Name Time Method To evaluate any prognostic indicators from the electrophysiological and device data in combination with basic demographic and outcome data.<br>To evaluate 'real world' usability of the EvokeTM Closed Loop SCS System.