Chronic PainFreshwaterNCT04662905
Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain
A study testing Evoke Spinal Cord Stimulation (SCS) System in people with Chronic Pain, run by Saluda Medical Pty Ltd at 25 sites in Australia.
Trial summary
The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 25 sitesAustralia
- Study dates
- 15 Dec 2020to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 1. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.
- 2. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
Who cannot join
- N/A
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nancy O'Connell, Director, Global Clinical Operations contact
25 sites in 1 country
Australia25 sites, 20 recruiting
- Recruiting
Interventus Pain Specialists
Auchenflower, Queensland, 4066
- Recruiting
Sydney Pain Specialists
Bella Vista, New South Wales, 2153
- Recruiting
Axxon Pain Medicine
Brisbane, Queensland, 4000
- Recruiting
Total Pain Clinic
Brisbane, Queensland, 4014
- Recruiting
Genesis Research Services
Broadmeadow, New South Wales, 2292
- Recruiting
Northern Integrated Pain Management
Charlestown, New South Wales, 2290
- Recruiting
Monash Clinical Research
Clayton, Victoria, 3168
- Recruiting
PainCare Perth
Cottesloe, Western Australia, 6011
- Recruiting
Precision Health
Doncaster East, Victoria, 3109
- Completed
QPAIN
Fortitude Valley, Queensland, 4006
- Recruiting
Frankston Pain Management
Frankston, Victoria, 3199
- Recruiting
ACT Pain Centre
Garran, Australian Capital Territory, 2605
- Recruiting
Pain Matrix
Geelong, Victoria, 3220
- Recruiting
Australian Medical Research
Hurstville, New South Wales, 2220
- Recruiting
Inner West Pain Centre
Newtown, New South Wales, 2042
- Completed
Sunshine Coast Clinical Research
Noosa, Queensland, 4567
- Completed
Paul Frank Medical Services
Peregian Beach, Queensland, 4573
- Recruiting
Melbourne Pain Specialists
Richmond, Victoria, 3121
- Recruiting
Pain Specialists Australia
Richmond, Victoria, 3121
- Recruiting
Managing Pain Clinic
Robina, Queensland, 4226
- Recruiting
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
- Recruiting
Northern Pain Centre
St Leonards, New South Wales, 2065
- Completed
Women's Health & Research Institute of Australia
Sydney, New South Wales, 2000
- Completed
Sydney Pain Research Centre Pty Ltd
Wahroonga, New South Wales, 2076
- Recruiting
CerCare Pty Ltd
Wayville, South Australia, 5034
About this study
Official title: A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.
- 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
ECAP-controlled, closed-loop SCS
| Study group | Role | What they receive |
|---|---|---|
| ECAP-controlled, closed-loop SCS | Experimental | 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.
Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start15 Dec 2020
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saluda Medical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy O'Connell, Study director, Saluda Medical Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662905
- Sponsor's protocol ID
- CLIN-PCL-007873
- Acronym
- Freshwater
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2020
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parker DJ, Antony AB, Smith GL, Goree JH, Russo MA, Petersen EA, Vu CM, Verrills P, Gilmore C, Kapural L, Nanavati D, Karantonis DM, Pope JE. Next-Generation SCS Programming Platform: Enhancing ECAP Fidelity and Objectivity to Improve Patient Experience. Pain Ther. 2026 Apr;15(2):465-480. doi: 10.1007/s40122-025-00808-5. Epub 2026 Jan 8.
PubMed 41505067
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
- ClinicalTrials.gov ID
- NCT04662905
- Acronym / sponsor ID
- Freshwater / CLIN-PCL-007873
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Saluda Medical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 10 Dec 2020 (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 purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECAP-controlled, closed-loop SCS | Experimental | 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
Key inclusion criteria (2 listed)
- 1. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.
- 2. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
Key exclusion criteria (1 listed)
- N/A
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) SystemECAP-controlled, closed-loop SCS | Device | ECAP-controlled, closed-loop SCS |
Primary outcome
Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Time frame: Through study completion, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 41505067Parker DJ, Antony AB, Smith GL, Goree JH, Russo MA, Petersen EA, Vu CM, Verrills P, Gilmore C, Kapural L, Nanavati D, Karantonis DM, Pope JE. Next-Generation SCS Programming Platform: Enhancing ECAP Fidelity and Objectivity to Improve Patient Experience. Pain Ther. 2026 Apr;15(2):465-480. doi: 10.1007/s40122-025-00808-5. Epub 2026 Jan 8.
- 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.
Nancy O'Connell, Director, Global Clinical Operations contact
Nancy O'Connell study director
Saluda Medical Pty Ltd
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evoke Spinal Cord Stimulation (SCS) System in people with Chronic Pain, run by Saluda Medical Pty Ltd at 25 sites in Australia.
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 2 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy O'Connell, Director, Global Clinical Operations (612-867-7383, nancy.oconnell@saludamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System (time frame: Through study completion, up to 2 years). 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 NCT04662905, 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 20 Oct 2026.