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

Saluda Medical Pty Ltd23 sites in 1 country200 target enrollmentDecember 15, 2020

ConditionsChronic Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Saluda Medical Pty Ltd
Enrollment: 200
Locations: 23
Primary Endpoint: Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 15, 2020

End Date

January 1, 2027

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Saluda Medical Pty Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.
•Subject is willing and capable of giving informed consent and able to comply with study-related requirements.