This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for APM in the Evoke SCS System to Program Patients With Chronic Pain of the Trunk and/or Limbs (NCT06057480), a na na study. The primary outcome is Succsessful Use of APM.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06057480 |
| Phase | NA |
| Condition | Chronic Pain, Pain, Chronic |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Saluda Medical Pty Ltd |
| Results posted | Yes |
2. Clinical Question
Population
People with chronic pain of the trunk and/or limbs were the intended population. The registry record lists chronic pain as the condition and reports enrollment of 30 participants. It does not report further eligibility details or a fuller description of the participants in the primary outcome population.
Intervention
The study examined the Assisted Programming Module (APM), an investigational programming software module used with the Evoke Spinal Cord Stimulation System. The registry describes the device intervention and focuses the primary outcome on whether APM use generated a closed-loop program.
Comparator
There was no separate comparison group: the study is identified as single-group, with no allocation to groups. The registry record does not report a control arm or a randomized comparison. As a result, the primary result is a count of successful APM uses, not a difference between APM and another programming approach.
Primary question
Across APM uses through study completion, how often could the workflow generate a closed-loop program? The primary outcome description reports 134 (96%) successful uses. This is a measure of programming workflow performance as recorded in the study, not a patient-level comparison of pain outcomes or a test of whether the device changed participants’ health.
3. Trial Design
This was a prospective, multicenter, single-arm study of the Assisted Programming Module in the Evoke Spinal Cord Stimulation System. The registry lists the study as completed, with 30 participants enrolled. Its start date was 2023-09-26, and its primary completion date was 2024-12-19. The listed phase is NA, and masking is listed as none. The intervention is a device; the APM is described as investigational programming software.
The design centers on use of a programming workflow rather than a comparison of treatments. Because the study has one group, there is no concurrent control group in the registry record against which to estimate a relative effect. The record also does not report random allocation. The registry lists the APM as the study arm and describes the primary outcome as successful uses of APM, with observations across all timepoints through study completion, on average 3-months post-implant procedure.
The registry lists two outcome measures and no analyses. It identifies one primary outcome and a secondary outcome concerning time to generate an APM program when a closed-loop program was achieved. The registry record does not report analysis details for that secondary outcome, nor does it provide the number of participants contributing to each outcome. The sample-size justification, planned enrollment rationale, detailed protocol, and any interim analyses are not reported in the registry record.
These design features matter to interpretation. The prospective, multicenter structure identifies the kind of study conducted, but it does not by itself establish how participants were selected, how APM uses were counted, or how missing observations were handled. With a single group and a workflow-focused endpoint, the results describe performance recorded during study use. They do not estimate an effect relative to an alternative programming process.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Assisted Programming Module (APM) |
|---|---|
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: 30 enrolled patients
| Characteristic | Unit | Assisted Programming Module (APM) |
|---|---|---|
| Participants analysed | 30 | |
| Age, Customized: 100% of patients were >18 years of age | Participants | 30 |
| Sex: Female, Male: Female | Participants | — |
| Sex: Female, Male: Male | Participants | — |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Succsessful Use of APM, measured over All timepoints through study completion, on average 3-months post-implant procedure..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | APM successful uses |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled “Succsessful Use of APM” in the registry. It is expressed as the number of successful APM uses. The outcome description says that, of all APM uses, the workflow was able to generate a closed-loop program 134 (96%) times. Its timeframe covers all timepoints through study completion, on average 3-months post-implant procedure.
This endpoint is used to characterize whether the APM workflow can produce the specified program during its use. It therefore addresses a practical programming-process question: how often the recorded workflow reached the stated programming result. A count of successful uses can be informative about workflow operation, but it is not inherently a measure of change in pain, function, quality of life, or another patient-level clinical outcome. Those outcomes are not reported as the primary endpoint in the registry record.
The registry does not report the total number of APM uses in the endpoint description as a separate count, nor does it describe how multiple uses within the same participant were handled statistically. It also does not report a confidence interval for the result. Without those details, the result can be stated as reported, but its precision and the extent to which repeated uses from the same participant contribute to the aggregate cannot be determined from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary outcome description reports 134 (96%) successful uses among APM uses. In the registry’s terms, a successful use is one in which the workflow generated a closed-loop program. This is a descriptive result about recorded programming events. It should not be read as the percentage of participants who had a successful experience: the unit is APM uses, and the record does not report a participant-level success rate.
The distinction between uses and participants is important. The study enrolled 30 participants, while the primary endpoint counts uses. The registry record does not give a separate total number of APM uses or explain whether participants contributed different numbers of uses. Consequently, the reported 134 (96%) cannot establish how evenly successful outcomes were distributed across participants. It also cannot show whether success was consistent across study sites or timepoints, because such breakdowns are not reported in the registry record.
The study is single-arm and has no reported control group. The result therefore has no direct within-study benchmark for comparing APM with another programming method. It describes what happened during APM use in this study, not a relative difference attributable to the module. The registry record does not report an adjusted estimate, an uncertainty interval, or an inferential analysis for the primary outcome. No p-value or statistical test for this outcome is reported in the registry record.
The result is also not a clinical efficacy estimate. The endpoint concerns generation of a closed-loop program, whereas the primary outcome description does not report pain improvement or another patient health outcome. Even if a workflow endpoint is relevant to understanding device programming, the reported count alone does not establish a change in symptoms or the comparative value of the programming module. Such conclusions would require relevant outcome definitions and analyses, which are not reported in the registry record.
Some parts of the study context are available: it was prospective and multicenter, enrolled 30 participants, and assessed APM use through completion, on average 3-months post-implant procedure. Other details needed to judge how broadly the result applies—including participant characteristics, site-level results, eligibility criteria, and the number of APM uses per participant—are not reported in the registry record. The result is best understood as the registry’s aggregate description of successful programming workflow uses, with limited information about its precision and distribution.
9. Statistical Methods Explained
The primary result is a count accompanied by a percentage: 134 (96%) successful APM uses. A count communicates how many events met the stated definition, while a percentage expresses that count relative to a denominator. Here, the description identifies the denominator broadly as all APM uses, but the total number of uses is not separately reported in the registry record. The percentage can be quoted as posted, but a reader cannot reconstruct the underlying denominator from the registry information without making an unsupported inference.
What does a count measure?
A count outcome records the number of times a defined event occurs. In this study, the event is an APM workflow generating a closed-loop program. A count is different from a continuous measure such as time, and different from a patient-level outcome such as the proportion of participants meeting a clinical threshold. The unit of analysis matters: the primary outcome is described in successful uses, not in participants. The registry record does not specify whether each participant had the same number of uses or how the analysis accounted for repeated uses by the same person.
As a general statistical point, repeated observations from one person may be more alike than observations from different people. If a count or proportion combines repeated uses as though each use were independent, uncertainty could be understated. Methods for clustered or repeated observations can account for that dependence, but the registry record does not report which, if any, were used. This is a methodological consideration, not evidence that the posted result used an inappropriate method.
How should a percentage be read?
A percentage is useful for expressing frequency relative to a denominator, but its precision depends in part on the amount of information behind it and on how observations are related. A confidence interval is a range of values compatible with the data under a specified statistical model; it conveys uncertainty around an estimate rather than a guarantee about where the true value lies. No confidence interval for the primary result is reported in the registry record. The absence of an interval means the posted percentage should be treated as a descriptive point estimate, not as a complete account of statistical precision.
For a repeated-use endpoint, interpreting precision would also require understanding the observation structure. For example, the number of uses per participant, the handling of incomplete attempts, and any grouping by site could affect the appropriate uncertainty calculation. Those details are not reported in the registry record. No estimate of between-participant variation or site variation is reported either.
What does the design allow?
In a single-arm study, results describe the participants and observations in the study group. A comparative effect generally requires a comparison condition and a defined contrast between groups or periods. The registry describes no control arm or randomized comparison for this study. Thus, the primary count is not an estimate of a difference between APM and another approach. It also is not a causal estimate of what would have occurred without APM.
The prospective, multicenter designation describes the study’s broad organization. It does not supply the missing details of the statistical analysis plan. The registry record lists two outcome measures and no analyses. It does not report a test statistic, model, adjustment strategy, handling of repeated observations, confidence interval, or prespecified analysis population. These omissions limit assessment of how the primary count was derived beyond the description posted.
How do planning illustrations differ from study results?
Sample-size planning is a design exercise: it considers how much information might be needed to detect a specified effect under selected assumptions. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. For non-time-to-event outcomes, such illustrations are expressed as participants per arm for 80% power or other specified power levels; time-to-event calculations use a total number of events. These are planning concepts, not observed outcomes.
The study itself is single-arm, while those planning assumptions describe equal allocation between two arms. The planning illustration is therefore not a description of the actual allocation in this study. The resulting sample-size values are not reported in the registry record, and the registry does not report that these assumptions were the trial’s own design justification. Such calculations should not be interpreted as observed power or as evidence that the study was adequately sized for its endpoint.
Over-dispersion is a general issue for count data: it occurs when the variability in counts is greater than a simple model assumes. If present, a model that allows extra variation may give more appropriate uncertainty estimates. The registry record does not report a count model, dispersion assessment, or an estimate of variability for APM uses. No conclusion about over-dispersion can be drawn from the aggregate result alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures: the primary measure of successful APM uses and a secondary measure of time to generate an APM program when a closed-loop program was achieved. It reports no analyses. The registry record does not describe a prespecified statistical analysis plan, a testing hierarchy, or any method for controlling multiplicity across outcomes or analyses. It is therefore not possible to determine from the record whether multiplicity was addressed or whether the secondary outcome was analyzed.
Multiplicity refers generally to the increased chance of a false-positive finding when multiple statistical tests are conducted. A prespecified hierarchy or adjustment can address that issue in some settings. Because inferential tests and their plan are not reported, no claim about the consequences of multiplicity in this study is warranted. The primary result is presented descriptively in the registry, without a reported p-value or confidence interval.
Missing-data methods are also not reported in the registry record. The outcome timeframe includes all timepoints through study completion, but the record does not state how incomplete programming attempts, unavailable observations, or participants with no recorded use were treated. Nor does it report the number of observations omitted or a sensitivity analysis for missing data. This matters because the interpretation of a percentage depends on which uses are included in its denominator.
The registry record does not define an analysis population for the primary outcome or report how enrollment relates to the set of participants contributing uses. It does not state whether all enrolled participants were included in the endpoint calculation. These are reporting gaps; they do not establish that observations were missing or excluded. The posted result should therefore be read with its stated unit—APM uses—and without assuming a particular approach to missing data or population selection.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Assisted Programming Module (APM) | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Assisted Programming Module (APM) | 0 of 30 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Assisted Programming Module (APM) | 0 of 30 |
The registry lists 30 participants at risk in the APM group. It records 0 serious adverse events, 0 other adverse events, and 0 deaths. No serious adverse event terms are listed. These figures are the safety counts recorded in the registry for this study group; they are not a comparison with an untreated or alternative-treatment group.
A recorded count of zero means that no events of the listed category were recorded in the registry results for the stated group. It does not establish that the risk of an event is zero, and it does not show how safety would compare under another programming approach. The registry record does not report additional details about how adverse events were defined, collected, assessed for relationship to the intervention, or followed over time. The primary outcome timeframe is described, but a specific safety follow-up period is not reported in the registry record.
These safety figures should be read as registry-reported counts, not as a complete evaluation of all possible risks. The record does not provide event narratives or a breakdown by participant characteristics. The study’s 30 enrolled participants and the reported safety counts give context for the scale of the available safety information, but the record does not report a statistical comparison or uncertainty estimate for those counts.
12. What the Result Does, and Does Not, Mean
The result shows that the registry describes 134 (96%) of all APM uses as workflows that generated a closed-loop program. That finding speaks to the study’s stated programming-process endpoint. It gives a descriptive account of successful uses across the reported timeframe, which extended through study completion and was on average 3-months post-implant procedure.
The result does not establish that APM improved pain, function, or another clinical outcome. The primary endpoint is not a patient-reported health measure; it is a count of successful programming uses. The registry record does not report a comparative clinical outcome analysis. It also does not establish that APM performs better or worse than another programming method, because the study is single-arm and has no reported comparison group.
The result should not be interpreted as the share of participants for whom APM succeeded. The unit is uses, and the number of uses per participant is not reported. Nor does the aggregate result show whether success varied between participants, sites, or timepoints. The registry record does not report a confidence interval or analysis of variation, so the precision of the percentage cannot be assessed from the posted result alone.
The study enrolled 30 participants and is listed as completed. This context describes the study scale and status, but enrollment does not supply the missing denominator for the use-based endpoint. It also does not establish that all enrolled participants contributed equally or that all possible uses were captured. The registry record does not report those details.
In short, the posted outcome is evidence about the frequency of a defined workflow result in this study’s recorded APM uses. It is not evidence, on its own, of comparative effectiveness, patient benefit, or performance in populations beyond those studied. The record supports the descriptive statement and no broader causal conclusion.
13. Why This Trial Matters Statistically
This study is statistically distinctive because its primary endpoint is a workflow count rather than a conventional participant-level clinical outcome. That difference affects how the result should be summarized, what the denominator means, and which methods may be appropriate. Reporting 134 (96%) successful uses identifies the observed aggregate frequency, but evaluating its uncertainty would require information about the total uses and how those uses were distributed across participants.
For clinical researchers, the distinction between the number of participants and the number of observations is important. Multiple uses from one participant are not automatically equivalent to the same number of independent participants. General methods for clustered data can address dependence when the design and data structure are known. The registry record does not report the use-level structure or the analysis method, making it difficult to assess precision beyond the posted percentage.
The single-arm design also frames the statistical question. It can describe how often the workflow reached its stated target in the study, but it does not provide a randomized comparison or a relative effect against another programming approach. This is not a defect in the descriptive purpose of the endpoint; it is a boundary on the conclusions that can be drawn from it.
Finally, the registry’s limited analysis reporting illustrates why outcome definitions, denominators, analysis populations, and uncertainty estimates matter. The result is interpretable at a basic descriptive level, but important details needed to judge precision and reproducibility are not reported in the registry record. That distinction helps keep an operational finding separate from claims about clinical outcomes or comparative performance.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations are specific to the information reported for this study. The primary endpoint is use-based, but the registry does not report the total number of APM uses separately from the stated count and percentage. It also does not describe how many uses came from each participant. This prevents assessment of whether the aggregate result reflects broadly similar experience across participants or a different distribution of repeated observations.
The record does not report a confidence interval, an inferential test, or a statistical model for the primary outcome. It therefore gives no direct estimate of uncertainty around 134 (96%). Details about incomplete attempts, missing observations, and the denominator used for the percentage are not reported in the registry record. These gaps limit the ability to reproduce or independently assess the endpoint calculation.
The single-arm design has no reported concurrent comparator, so the result cannot estimate a contrast with another programming approach. The registry does not provide site-level or participant-level outcomes, and it does not report characteristics that would allow readers to assess how closely the enrolled group represents other populations with chronic pain of the trunk and/or limbs. Eligibility criteria and detailed participant characteristics are not reported in the registry record.
The registry lists a secondary measure of time to generate an APM program when a closed-loop program was achieved, but no analysis is reported. The protocol, statistical analysis plan, missing-data strategy, safety ascertainment details, and rationale for sample size are not reported in the registry record. These are limits of the available reporting and should not be taken as evidence that the underlying study did not address them.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: APM in the Evoke SCS System to Program Patients With Chronic Pain of the Trunk and/or Limbs — NCT06057480.
- Registry record last updated 2026-09-25; status last verified 2026-09.
- Results first posted 2026-09-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes NCT06057480, “APM in the Evoke SCS System to Program Patients With Chronic Pain of the Trunk and/or Limbs,” as a prospective, multicenter, single-arm study sponsored by Saluda Medical Pty Ltd. The listed intervention is the Evoke Spinal Cord Stimulation System, with the Assisted Programming Module as the investigational programming software. The study is completed, with 30 participants enrolled.
The primary outcome is successful use of APM, defined in the outcome description as generation of a closed-loop program. The record reports 134 (96%) successful uses among all APM uses through study completion, on average 3-months post-implant procedure. It also lists time to generate an APM program when a closed-loop program was achieved as a secondary outcome. The registry lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 30 at risk. It reports no analyses. The total number of uses, uncertainty estimates, analysis methods, and detailed outcome-population information are not reported in the registry record.