A Prospective Study to Evaluate the Long-term Effectiveness, Safety, and Performance of the Saluda Medical's EvokeTM Closed-Loop Spinal Cord Stimulation System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

Saluda Medical Pty Ltd8 sites in 4 countries70 target enrollmentAugust 5, 2020

ConditionsChronic Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Saluda Medical Pty Ltd
Enrollment: 70
Locations: 8
Primary Endpoint: Percent Change in Visual Analogue Scale (VAS) Pain
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the Evoke System in the treatment of chronic pain of the trunk and/or limbs in a real-world population.

Registry

clinicaltrials.gov

Start Date

August 5, 2020

End Date

December 31, 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Saluda Medical Pty Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Eligible for therapy according to the Evoke System indications for use statement and labelling requirements
•Willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits
•Baseline VAS pain rating ≥60 mm in the primary area of pain

Exclusion Criteria

•No further exclusion criteria

Outcomes

Primary Outcomes

Percent Change in Visual Analogue Scale (VAS) Pain

Time Frame: 3-months post-implant

Visual Analogue Scale (VAS) to rate pain intensity (0mm \[no pain\] to 100mm \[worst pain imaginable\])

Secondary Outcomes

Incidence of device- and procedure-related adverse events(through 60-months post-implant)
Measurement of ECAPs by the Evoke SCS System(through 60-months post-implant)