Chronic PainAPMNCT06057480
APM in the Evoke SCS System to Program Patients With Chronic Pain of the Trunk and/or Limbs
A study testing Evoke Spinal Cord Stimulation System in people with Chronic Pain and Pain, Chronic, run by Saluda Medical Pty Ltd at 4 sites in United States.
Trial summary
Study to evaluate the use of the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to program patients with chronic pain of the trunk and/or limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Pain, Chronic
- What is being tested?
- Evoke Spinal Cord Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Sep 2023to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject has or is planning to undergo a temporary trial with Evoke System within the FDA approved indication.
- Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Orthopaedic Institute, PA
Gainesville, Florida, 32607
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Pacific Research Institute
Santa Rosa, California, 95403
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Prospective, Multicenter, Single-arm Study Examining the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to Program Patients With Chronic Pain of the Trunk and/or Limbs
Study to evaluate the use of the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to program patients with chronic pain of the trunk and/or limbs.
- Conditions
- Chronic Pain, Pain, Chronic
- Being tested
- Evoke Spinal Cord Stimulation 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 SystemDevice
ECAP-controlled closed loop with investigational programming software module, the Assisted Programming Module (APM)
| Study group | Role | What they receive |
|---|---|---|
| APM | Experimental | Investigational programming software module, the Assisted Programming Module (APM) Receives: Device: Evoke Spinal Cord Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Succsessful Use of APM
Of all APM uses, the workflow was able to generate a closed-loop program 134 (96%) times.
Measured: All timepoints through study completion, on average 3-months post-implant procedure.
Secondary outcomes (1)
Time to Generate APM Program When Closed-loop Program Achieved
The time (minutes) for the APM to generate a closed-loop program
Measured: All uses through study completion in which APM was initiated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start26 Sep 2023
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 30 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
- NCT06057480
- Sponsor's protocol ID
- D103684
- Acronym
- APM
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2023
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Study Examining the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to Program Patients With Chronic Pain of the Trunk and/or Limbs
- ClinicalTrials.gov ID
- NCT06057480
- Acronym / sponsor ID
- APM / D103684
- Conditions
- Chronic Pain, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Saluda Medical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Posted 25 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the use of the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to program patients with chronic pain of the trunk and/or limbs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APM | Experimental | Device: Evoke Spinal Cord Stimulation SystemInvestigational programming software module, the Assisted Programming Module (APM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has or is planning to undergo a temporary trial with Evoke System within the FDA approved indication.
- Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
Key exclusion criteria (1 listed)
- There are no 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 SystemECAP-controlled closed loop with investigational programming software module, the Assisted Programming Module (APM) | Device | APM |
Primary outcome
Succsessful Use of APM
Time frame: All timepoints through study completion, on average 3-months post-implant procedure.
Of all APM uses, the workflow was able to generate a closed-loop program 134 (96%) times.
1 secondary outcome
Time to Generate APM Program When Closed-loop Program Achieved
Time frame: All uses through study completion in which APM was initiated
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 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 System in people with Chronic Pain and Pain, Chronic, run by Saluda Medical Pty Ltd at 4 sites in United States.
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: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Succsessful Use of APM (time frame: All timepoints through study completion, on average 3-months post-implant procedure.). 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 NCT06057480, 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 25 Sep 2026.