Data collection from the Evoke™ System in the treatment of patients with chronic pain of the trunk and/or limbs
| ISRCTN | ISRCTN27710516 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27710516 |
| IRAS number | 263446 |
| ClinicalTrials.gov number | NCT05272137 |
| Secondary identifying numbers | IRAS 263446 |
- Submission date
- 24/06/2020
- Registration date
- 07/07/2020
- Last edited
- 08/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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 Evoke™ 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 Evoke™ 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 Evoke™ 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 Evoke™ SCS system.
Where is the study run from?
4 hospitals in the United Kingdom
When is the study starting and how long is it expected to run for?
From June 2019 to June 2023
Who is funding the study?
Saluda Medical Europe Ltd (UK)
Who is the main contact?
Mr Dave Mugan
dave.mugan@saludamedical.com
Contact information
Scientific
9 Hornbeam Square South
Hornbeam Park
Harrogate
HG2 8NB
United Kingdom
| Phone | +44 7557370074 |
|---|---|
| dave.mugan@saludamedical.com |
Study information
| Study design | Multicentre prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study 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(s) | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 17/06/2019 |
| Overall study end date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 148 |
| 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 exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 25/06/2020 |
| Recruitment end date | 22/11/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Great George St
Leeds
LS1 3EX
United Kingdom
West Smithfield
London
EC1A 7BE
United Kingdom
Westbury on Trym
Bristol
BS10 5NB
United Kingdom
Marton Rd
Middlesbrough
TS4 3BW
United Kingdom
Wigginton Road
York
YO31 8HE
United Kingdom
Sponsor information
Industry
9 Hornbeam Square South
Hornbeam Park
Harrogate
HG2 8NB
United Kingdom
| Phone | +44 7557370074 |
|---|---|
| dave.mugan@saludamedical.com | |
| Website | https://www.saludamedical.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Data will be published at the completion of the study. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
08/01/2024: The following changes were made to the trial record:
1. The study participating centre Guys' & St Thomas' Hospital was removed and York and Scarborough Teaching Hospitals NHS Foundation Trust was added.
2. The overall end date was changed from 30/09/2023 to 30/06/2023.
3. The intention to publish date was changed from 31/03/2024 to 31/01/2024.
27/12/2023: The following changes have been made:
1. The total final enrolment has been changed from 33 to 148.
2. The intention to publish date has been changed from 31/12/2023 to 31/03/2024.
20/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 22/12/2023 to 22/11/2022.
2. The overall trial end date was changed from 22/12/2025 to 30/09/2023.
3. The intention to publish date was changed from 01/07/2026 to 31/12/2023.
4. Total final enrolment and ClinicalTrials.gov number added.
01/07/2020: Trial’s existence confirmed by Yorkshire & The Humber - South Yorkshire Research Ethics Committee.
