PMCF study CLIN-PLC-005299
Research type
Research Study
Full 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
IRAS ID
279074
Contact name
Dave Mugan
Contact email
Sponsor organisation
Saluda Medical Europe Ltd
Clinicaltrials.gov Identifier
NL8791, Registration Dutch Trial register
Duration of Study in the UK
7 years, 1 months, 1 days
Research summary
This is a prospective study to evaluate the long-term effectiveness, safety, and performance of the Saluda Medical’s Evoke Closed-Loop Spinal Cord Stimulation System to treat patients with chronic pain of the trunk and/or limbs. This CE marked device under study is the EVOKE System and this system has been available on the market since 17th June 2019. This study is a post market clinical follow up study. The system measures the electrical response from the nerves and uses these to automatically alter the stimulation strength. This study is designed to confirm the long-term effectiveness, safety, and performance of the Evoke System by asking participants to complete a number of questionnaires over approximately 5 years.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0255
Date of REC Opinion
10 Nov 2020
REC opinion
Further Information Favourable Opinion