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NCT04627974 Clinical Trial

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

Chronic Pain Clinical Trial

— Domburg  

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04627974
Other study ID # CLIN-PLC-005299
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 5, 2020
Est. completion date December 31, 2027

Study information
Verified date April 2023
Source Saluda Medical Pty Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date December 31, 2027
Est. primary completion date April 3, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Evoke Spinal Cord Stimulation (SCS) System
A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Locations
Country Name City State
Belgium AZ Delta Multidisciplinary Pain Center Roeselare West Flanders
Belgium AZ Nikolaas Multidisciplinary Pain Center Sint-Niklaas East Flanders
Germany Universität Düsseldorf Düsseldorf North Rhine-Westphalia
Netherlands Erasmus University Medical Center Rotterdam
Netherlands Rijnstate Velp
United Kingdom Basildon University Hospital Basildon Essex
United Kingdom Southmead Hospital Bristol
United Kingdom James Cook University Hospital Middlesbrough North Yorkshire

Sponsors (1)
Lead Sponsor Collaborator
Saluda Medical Pty Ltd

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent Change in Visual Analogue Scale (VAS) Pain Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable]) 3-months post-implant
Secondary Incidence of device- and procedure-related adverse events through 60-months post-implant
Secondary Measurement of ECAPs by the Evoke SCS System through 60-months post-implant
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