A Clinical Study to Evaluate the Clinical Performance of HF10™ SCS Therapy in Failed Back Surgery Syndrome Patients in the Dutch Healthcare System

evro Corp.0 sites55 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Observational non invasive

Sponsor

evro Corp.

•1\.Diagnosed with Failed Back Surgery Syndrome which has been refractory to conservative therapy for a minimum of 3 months and indicated for SCS as per Dutch SCS guidelines and as approved by the Dutch insurance companies
•2\.Average leg pain intensity of ¡Ý 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
•3\.Average back pain intensity ¡Ü average leg pain intensity on the Visual Analog Scale (VAS) at enrollment
•4\.An adult (¡Ý 18 years of age) at time of enrollment

•1\.A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints,
•2\.Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
•3\.A diagnosis of scoliosis that precludes lead placement
•4\.Radiographic evidence of mechanical spinal instability requiring fusion.
•5\.Pain that is significantly exacerbated by activity or significantly alleviated by rest
•6\.Benefitting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat back and/or leg pain
•7\.Existing drug pump and/or SCS system or another active implantable device such as a pacemaker (switched On or Off)
•8\.Prior experience with SCS
•9\.Pregnant