Chronic PainNCT05272137
Evoke Data Collection Study Germany
An observational study of Chronic Pain, run by Saluda Medical Pty Ltd at 1 site in Germany.
Trial summary
The objective of this multicentre study is to collect electrophysiological and device data from the Evoke Closed-Loop SCS system in the treatment of chronic pain of the trunk and/or limbs, in a real world setting under normal conditions of use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Evoke Spinal Cord Stimulation (SCS) System
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteGermany
- Study dates
- 4 Feb 2022to 17 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients, age ≥ 18 years, suffering from chronic pain in the trunk and/or limbs, whom are implanted with the Saluda Medical Evoke SCS system.
Who may be able to join
- Patient approval for data collection and transfer of de-identified data to sponsor.
Who cannot join
- No further exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official 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
The objective of this multicentre study is to collect electrophysiological and device data from the Evoke Closed-Loop SCS system in the treatment of chronic pain of the trunk and/or limbs, in a real world setting under normal conditions of use.
- Conditions
- Chronic Pain
- Being tested
- Evoke Spinal Cord Stimulation (SCS) System
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evoke Spinal Cord Stimulation (SCS) SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| ECAP-controlled, closed-loop SCS | Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude Receives: Device: Evoke Spinal Cord Stimulation (SCS) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECAP Measurement in Microvolts
Evoked Compound Action Potentials (ECAPs) as a measure of spinal cord activation
Measured: through 6 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start4 Feb 2022
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saluda Medical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272137
- Sponsor's protocol ID
- D100967
- Status last verified
- Apr 2023
- First submitted
- 13 Jan 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nijhuis H, Kallewaard JW, van de Minkelis J, Hofste WJ, Elzinga L, Armstrong P, Gultuna I, Almac E, Baranidharan G, Nikolic S, Gulve A, Vesper J, Dietz BE, Mugan D, Huygen FJPM. Durability of Evoked Compound Action Potential (ECAP)-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) in a Real-World European Chronic Pain Population. Pain Ther. 2024 Oct;13(5):1119-1136. doi: 10.1007/s40122-024-00628-z. Epub 2024 Jul 2.
PubMed 38954217
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05272137
- Acronym / sponsor ID
- D100967
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Saluda Medical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this multicentre study is to collect electrophysiological and device data from the Evoke Closed-Loop SCS system in the treatment of chronic pain of the trunk and/or limbs, in a real world setting under normal conditions of use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECAP-controlled, closed-loop SCS | – | Device: Evoke Spinal Cord Stimulation (SCS) SystemSpinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients, age ≥ 18 years, suffering from chronic pain in the trunk and/or limbs, whom are implanted with the Saluda Medical Evoke SCS system.
Key inclusion criteria (1 listed)
- Patient approval for data collection and transfer of de-identified data to sponsor.
Key exclusion criteria (1 listed)
- No further exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evoke 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 | Device | ECAP-controlled, closed-loop SCS |
Primary outcome
ECAP Measurement in Microvolts
Time frame: through 6 months post-implant
Evoked Compound Action Potentials (ECAPs) as a measure of spinal cord activation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 38954217Nijhuis H, Kallewaard JW, van de Minkelis J, Hofste WJ, Elzinga L, Armstrong P, Gultuna I, Almac E, Baranidharan G, Nikolic S, Gulve A, Vesper J, Dietz BE, Mugan D, Huygen FJPM. Durability of Evoked Compound Action Potential (ECAP)-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) in a Real-World European Chronic Pain Population. Pain Ther. 2024 Oct;13(5):1119-1136. doi: 10.1007/s40122-024-00628-z. Epub 2024 Jul 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Saluda Medical Pty Ltd at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECAP Measurement in Microvolts (time frame: through 6 months post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.