Condition category
Signs and Symptoms
Date applied
24/06/2020
Date assigned
07/07/2020
Last edited
02/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic pain is pain that is ongoing and usually lasts longer than six months despite medication or treatment. This pain can be a result of illness or injury, or the cause may be unknown or unclear. Spinal Cord Stimulation (SCS), where a device is implanted beneath the skin using surgery and is then used to deliver an electric current to the nerves of the site of the pain, can be used to relieve chronic pain.

Saluda Medical has developed the EvokeTM SCS System, a new type of SCS system, which can make some nerve recordings from the wires while they are in place close to the nerves. The system measures the electrical response from the nerves and uses these to automatically alter the stimulation strength. By keeping the strength of the stimulation within a narrow range the patient no longer feels abrupt changes in stimulation and can move around without over or under-stimulation.

This study aims to collect data from the EvokeTM Closed-Loop SCS system from Saluda Medical to evaluate this system in a 'real-world' setting.

Who can participate?
Adult patients suffering from chronic pain in the trunk and/or limbs who are routinely scheduled for spinal cord stimulation with Saluda Medical System

What does the study involve?
Participants will receive the EvokeTM Spinal Cord Stimulation System for treatment of chronic pain of the trunk and/or limbs. Participation will not involve additional visits, tests nor the completion of any questionnaires. The data will be downloaded from the battery during routine visits over a period of 2 years when the patients normally visit the hospital for follow-up. Participants will be asked for approval to use the data stored in the battery.

What are the possible benefits and risks of participating?
There are no extra risks in taking part in this data collection. The trial will only use data that will be downloaded from the EvokeTM SCS system.

Where is the study run from?
5 hospitals in the United Kingdom

When is the study starting and how long is it expected to run for?
From June 2019 to December 2025

Who is funding the study?
Saluda Medical Europe Ltd (UK)

Who is the main contact?
Mr Dave Mugan
dave.mugan@saludamedical.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Dave Mugan

ORCID ID

Contact details

9 Hornbeam Square South
Hornbeam Park
Harrogate
HG2 8NB
United Kingdom
+44 7557370074
dave.mugan@saludamedical.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 263446

Study information

Scientific title

Prospective data collection to evaluate the feedback control of the Saluda Medical's Evoke™ Spinal Cord Stimulation System in the treatment of patients with chronic pain of the trunk and/or limbs

Acronym

Evoke™ Data Collection

Study hypothesis

To evaluate the electrophysiological and device data and the programmability of the Evoke™ Closed-Loop SCS system from Saluda Medical in a 'real-world' setting under normal clinical use.

Ethics approval

Approved 05/08/2019, Yorkshire & The Humber - South Yorkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne NE2 4NQ UK; +44 (0)207 1048091; nrescommittee.yorkandhumber-southyorks@nhs.net), ref: 19/YH/0253

Study design

Multicentre prospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Chronic pain in the trunk and/or limbs

Intervention

This prospective data collection is purely observational and does not include any intervention. Data collection on the electrophysiological and device data and the programmability of the Saluda Medical EvokeTM Closed-Loop SCS System for the treatment of patients with chronic trunk and/or limb pain followed for 2 years. The data will be automatically downloaded during standard of care visits between baseline and 2 years. The patients will not have any additional visits, questionnaires, or interventions outside the normal standard care.

Intervention type

Device

Phase

Not Applicable

Drug names

Saluda Medical Evoke™ Closed-Loop Spinal Cord Stimulation system

Primary outcome measure

Collection of electrophysiological and device data from the EvokeTM ClosedLoop SCS system automatically downloaded during standard of care visits between baseline and 2 years, collected at 2 years

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

17/06/2019

Overall trial end date

22/12/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥18 years
2. Suffering from chronic pain in the trunk and/or limbs
3. Routinely scheduled for spinal cord stimulation with Saluda Medical System
4. Consent given for prospective data collection and transfer of de-identified data to Saluda Medical

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

25/06/2020

Recruitment end date

22/12/2023

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds General Infirmary
B Floor, Brotherton Wing Great George St
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Barts Health NHS Trust
St Bartholomew’s Hospital West Smithfield
London
EC1A 7BE
United Kingdom

Trial participating centre

North Bristol Trust
Southmead Hospital Westbury on Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

South Tees Hospitals
The James Cook University Hospital Marton Rd
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

Guys' & St Thomas' Hospital
St Thomas Hospital Westminster Bridge Rd
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Saluda Medical Europe Ltd

Sponsor details

9 Hornbeam Square South
Hornbeam Park
Harrogate
HG2 8NB
United Kingdom
+44 7557370074
dave.mugan@saludamedical.com

Sponsor type

Industry

Website

https://www.saludamedical.com/

Funders

Funder type

Industry

Funder name

Saluda Medical Europe Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Data will be published at the completion of the study.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to fact that the device data is collected for sponsor internal use only. The participating sites will be provided with a copy of their data upon request.

Intention to publish date

01/07/2026

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

NA

Publication citations

Additional files

Editorial Notes

01/07/2020: Trial’s existence confirmed by Yorkshire & The Humber - South Yorkshire Research Ethics Committee.