Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

Active, not recruiting

• Conditions: Chronic Pain
• Interventions: Device: Evoke Spinal Cord Stimulation (SCS) System

• Registration Number: NCT04627974
• Lead Sponsor: Saluda Medical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-05
• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-13
• Primary Completion: 2023-04-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-05
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECAP-controlled, closed-loop SCS	Evoke Spinal Cord Stimulation (SCS) System	Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Primary Outcome Measures

Name	Time	Method
Percent Change in Visual Analogue Scale (VAS) Pain	3-months post-implant	Visual Analogue Scale (VAS) to rate pain intensity (0mm \[no pain\] to 100mm \[worst pain imaginable\])

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

AZ Nikolaas Multidisciplinary Pain Center; 🇧🇪 Sint-Niklaas, East Flanders, Belgium

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

Basildon University Hospital; 🇬🇧 Basildon, Essex, United Kingdom

Universität Düsseldorf; 🇩🇪 Düsseldorf, North Rhine-Westphalia, Germany

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

Rijnstate; 🇳🇱 Velp, Netherlands

James Cook University Hospital; 🇬🇧 Middlesbrough, North Yorkshire, United Kingdom

AZ Delta Multidisciplinary Pain Center; 🇧🇪 Roeselare, West Flanders, Belgium