Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT04627974

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

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
70 (actual)
Sponsor
Saluda Medical Pty Ltd · Industry
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEEvoke Spinal Cord Stimulation (SCS) SystemA 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

Timeline

Start date
2020-08-05
Primary completion
2023-04-03
Completion
2027-12-31
First posted
2020-11-13
Last updated
2024-07-05

Locations

8 sites across 4 countries: Belgium, Germany, Netherlands, United Kingdom

Source: ClinicalTrials.gov record NCT04627974. Inclusion in this directory is not an endorsement.