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 Feasibility Study for Intrathoracic Nerve Stimulation (NCT04066374), a na na study. The primary outcome is Pain as Measured by the Visual-analog Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04066374 |
| Phase | NA |
| Condition | Postoperative Pain |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | The Cleveland Clinic |
| Results posted | Yes |
2. Clinical Question
Population
The registry identifies postoperative pain as the condition under study. The study description concerns people undergoing cardiothoracic surgery, with the aim of evaluating peripheral nerve stimulation of intercostal nerves for pain control after surgery. The record does not provide further eligibility details or describe the analyzed population for the primary outcome.
Intervention
The intervention is a peripheral nerve stimulation device, described as an intrathoracic placement of a neurostimulation device. The brief summary specifies an electrical lead placed in the thoracic cavity to stimulate intercostal nerves. The stated purpose is an early clinical evaluation of safety and feasibility, as well as pain control.
Comparator
There is no separate comparator group in the registered design. The study is listed as single-group, and allocation is recorded as NA. The Treatment Arm therefore cannot be interpreted as a randomized or like-for-like comparison against another treatment or control condition. Any baseline-to-follow-up description would remain within the single group.
Primary question
The primary endpoint is pain measured by the Visual-analog Scale from baseline to 3 months. The scale runs from 0 for no pain to 10 for unbearable pain, with lower scores representing a better outcome. The registry record does not report the observed pain values or an analysis of change over this timeframe, so it does not establish the size or precision of any change.
3. Trial Design
This is a completed, single-group feasibility study registered as NCT04066374, with the title “Feasibility Study for Intrathoracic Nerve Stimulation.” The official title is “Investigational Device Exemption for Intrathoracic Nerve Stimulation.” The sponsor is The Cleveland Clinic. The registry lists phase as NA, allocation as NA, masking as none, and the model as single group.
The registered intervention is peripheral nerve stimulation using an intrathoracic neurostimulation device. The Treatment Arm description specifies intrathoracic placement of the device. The brief summary describes an electrical lead in the thoracic cavity for stimulation of intercostal nerves. The stated purpose is an early clinical evaluation of safety and feasibility in pain control after cardiothoracic surgery.
Enrollment is recorded as 10. The registry lists the start date as 2019-08-13, primary completion as 2024-01-09, and status as completed. These design and status details describe the registered study; they do not establish how many participants contributed data to any particular endpoint.
The primary outcome is pain on the Visual-analog Scale from baseline to 3 months. The record also includes two outcome measures, but it lists zero analyses. No protocol-based rationale for the enrollment, sample-size justification, or statistical analysis plan is reported in the registry record. The posted design is not a randomized comparison, so the intervention group has no concurrent control arm in the registered structure. This limits interpretation to what can be described within the study and its recorded safety information, rather than a comparative estimate of treatment effect.
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 | Treatment Arm |
|---|---|
| STARTED | 10 |
| COMPLETED | 10 |
| 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.
| Characteristic | Unit | Treatment Arm |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 65.8 (56 to 78) |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 5 |
| Race/Ethnicity, Customized: Race – Caucasian | Participants | 9 |
| Race/Ethnicity, Customized: Race – Other | Participants | 1 |
| Baseline Pain Level | units on a scale | 0 (0 to 0) |
6. Primary Endpoint
The registry lists the primary outcome as Pain as Measured by the Visual-analog Scale, measured over Baseline to 3 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is pain as measured by the Visual-analog Scale, with the timeframe specified as baseline to 3 months. The registry describes a scale from 0, meaning no pain, to 10, meaning unbearable pain. Lower scores represent a better outcome. The measure captures the pain level expressed by the study subject, rather than an objective physiological measurement.
A pain rating is relevant to the study’s stated purpose because the intervention is being evaluated for pain control after cardiothoracic surgery. A repeated measure spanning baseline to follow-up can describe pain at different points in the course of observation. However, the record does not say whether the primary analysis was intended to compare endpoint scores, quantify change, or use another approach. That analysis detail is not reported in the registry record.
The endpoint is reported using a mean parameter and full range as its dispersion description. The registry record does not provide the observed mean, the range, or participant-level values. It also does not report an effect estimate or confidence interval. Consequently, the endpoint definition explains what was meant to be assessed, but the registered results do not show the level of pain observed or how precisely any change was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically relevant question: whether intrathoracic peripheral nerve stimulation can be evaluated for safety and feasibility in the setting of postoperative pain after cardiothoracic surgery. Its primary endpoint is pain on the Visual-analog Scale from baseline to 3 months. The study is described as an early clinical evaluation, and the design is single group rather than a randomized comparison.
The central limitation for interpreting the primary endpoint is that the registry record does not report its observed values or analysis. The registered scale and timeframe alone cannot show whether pain ratings changed, by how much they changed, or how variable those ratings were. The record also does not report a confidence interval or another measure of precision for the endpoint. Thus, no estimate of the size or uncertainty of a pain outcome can be drawn from the posted results.
The safety information includes Treatment Arm counts for serious adverse events, other adverse events, and deaths. The registry reports 4 affected for serious adverse events among 10 at risk, 9 affected for other adverse events among 10 at risk, and 0 deaths. It also lists several serious event terms at 10.0% each. These figures describe entries in the registry; in the absence of a comparison group, they do not establish whether the intervention caused an event or how the event frequency compares with another treatment or background risk.
The design also matters for causal interpretation. With one treatment group and no randomized comparator, changes over time cannot be separated from other influences on pain using a between-group contrast. General features of postoperative recovery, changes in care, and other factors could contribute to observed outcomes, but the record does not describe their measurement or handling. This is not evidence that any particular factor explains an outcome; it means that a single-group design cannot by itself distinguish such influences.
Enrollment is listed as 10, but enrollment is not necessarily the same as the number with complete endpoint data. The registry does not report the endpoint analysis population, missingness, or the number contributing observations at each time point. The zero listed analyses and absence of reported primary outcome results leave the clinical outcome question unresolved in this record. The available information supports a description of the planned endpoint and recorded safety counts, not a conclusion about the magnitude, precision, or causal meaning of a pain change.
9. Statistical Methods Explained
Statistical interpretation depends on distinguishing the registered design, the endpoint definition, and the results that are actually reported. The registry describes one group receiving intrathoracic peripheral nerve stimulation and does not list a separate comparator. It identifies a primary pain measure and timeframe, but no primary outcome analysis is reported in the registry record. General statistical principles can clarify what such an analysis would mean, but they cannot fill in missing study results.
What does a mean describe?
In general, a mean is a measure of the average observed values in a group. It can provide a compact description of pain ratings, but it does not show the full spread of individual ratings. Two groups or time points can have the same mean while differing in how dispersed their observations are. Here, the registry labels the primary parameter as a mean and its dispersion as a full range, but it does not report the observed mean or range. A reader therefore cannot assess either the average pain rating or the variability of recorded ratings from the registry results.
What does a full range show?
In general, a full range describes the lowest and highest observed values. It communicates the span of the observations, but not how closely values cluster around the mean or how uncertain the mean estimate is. A range can be strongly affected by observations at the extremes. It is not interchangeable with a standard deviation or a confidence interval. The registry record names full range as the dispersion measure, but gives no actual range values.
What would a confidence interval add?
In general, a confidence interval expresses the uncertainty around an estimated quantity under a specified statistical procedure. A narrower interval indicates greater precision for that estimate, while a wider interval indicates less precision. It does not guarantee that the estimate is unbiased, nor does it resolve limitations in the design. No confidence interval for the pain endpoint is reported in the registry record. Without an estimate and its uncertainty, readers cannot judge how compatible the data are with different possible pain outcomes.
Why is the single-group design important?
In general, a randomized comparison can help distinguish the effect of an intervention from changes that occur over time or differences between participants. This study is listed as single group, with allocation recorded as NA and masking as none. There is no registered comparison arm against which to estimate a treatment contrast. A before-and-after description, if reported, would be a within-group observation. Such an observation may describe what happened in the group, but alone it cannot isolate the intervention’s contribution from other influences.
How should planning calculations be read?
In general, a sample-size planning illustration asks how much information a future comparison might require under stated assumptions. It is not an observed study result and is not observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. Such assumptions do not establish the design used for this study. The registry does not report that this planning exercise was its own design rationale, and no protocol-based sample-size justification is reported.
The illustration is especially distinct from the registered study structure because the study is single group and has no like-for-like control comparison. Its assumptions describe a hypothetical two-arm planning setting, not the completed study’s observed design. Since the registry does not report an observed primary effect or outcome analysis, no study-specific estimate can be used to assess the assumptions or translate the illustration into evidence about the intervention.
What can the safety counts establish?
In general, safety counts describe recorded events or people affected according to the registry’s reporting convention. Their meaning depends on the event definitions, observation period, and whether the count is of events or affected participants. The registry lists the at-risk and affected figures, but does not describe those details in the outcome information presented. Without a comparator, the figures also do not quantify a difference in risk attributable to the device. They are descriptive entries, not a controlled estimate of comparative safety.
Finally, an analysis requires clarity about the observations included, how missing data are handled, and how the endpoint is calculated. Those details are not reported in the registry record. The record lists two outcome measures and zero analyses, but does not specify analysis populations, missing-data methods, or a multiplicity strategy. General statistical explanations cannot substitute for those missing study-specific methods or for the absent outcome estimates.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity concerns arise when a study evaluates more than one outcome, time point, subgroup, or analysis, because multiple statistical tests can increase the chance of a nominally unusual finding. The registry lists two outcome measures, but does not report a multiplicity adjustment or a hierarchy for interpreting outcomes beyond identifying the primary pain endpoint. The approach to multiplicity is not reported in the registry record.
The registry lists zero analyses. It does not report whether an analysis population was defined as all enrolled participants, those receiving the device, or those with observed endpoint data. The number contributing pain ratings at baseline or at 3 months is not reported in the registry record. Enrollment of 10 should not be treated as proof that every enrolled participant contributed complete outcome data.
Missing-data handling is also not reported. The record does not say whether missing ratings occurred, how any missing values were treated, or whether sensitivity analyses were planned. Without that information, the completeness and robustness of a primary endpoint analysis cannot be assessed. It would be inappropriate to assume that no data were missing merely because the registry does not describe missingness.
The registry record also does not report an analysis plan, interim analyses, or a rationale for the enrollment. These omissions prevent assessment of whether the posted endpoint analysis followed a prespecified statistical approach. They do not show that a particular method was or was not used; they indicate that the relevant information is not reported in the registry record.
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 |
|---|---|---|---|
| Treatment Arm | 4 | 10 | 40.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment Arm | 0 of 10 |
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 |
|---|---|
| Treatment Arm | 9 of 10 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment Arm |
|---|---|---|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | 1 of 10 |
| Acute Kidney Injury | Renal and urinary disorders | 1 of 10 |
| COPD | Respiratory, thoracic and mediastinal disorders | 1 of 10 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 1 of 10 |
| Emphysema | Respiratory, thoracic and mediastinal disorders | 1 of 10 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 1 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment Arm |
|---|---|---|
| Discomfort | General disorders | 5 of 10 |
| Discomfort | General disorders | 3 of 10 |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | 2 of 10 |
| Abdominal Pain | Gastrointestinal disorders | 1 of 10 |
Serious events with the highest arm-level rate: pleural effusion (10.0%), acute kidney injury (10.0%), copd (10.0%), pneumothorax (10.0%), emphysema (10.0%).
The Treatment Arm safety entries report 4 affected for serious adverse events among 10 at risk, 9 affected for other adverse events among 10 at risk, and 0 deaths. The registry separately lists Pleural Effusion, Acute Kidney Injury, COPD, Pneumothorax, Emphysema, and Pneumonia at 10.0% each among the top serious terms.
These are descriptive safety figures. The registry record does not provide further detail in these entries about event timing, duration, severity grading, recurrence, or attribution to the device. The listed terms should not be read as evidence that the device caused those events. Nor do the entries provide a comparison with another group, because the registered study is single group.
Counts of affected participants and counts of events are not necessarily interchangeable; the record does not clarify that distinction in the information available for these entries. The at-risk figures indicate the recorded group size for the safety summaries, but do not establish how many participants contributed primary pain measurements. The safety data provide context about reported events, not a controlled estimate of comparative safety or a complete account of clinical risk.
12. What the Result Does, and Does Not, Mean
The study is registered as a completed early clinical evaluation of intrathoracic peripheral nerve stimulation, with safety and feasibility among its stated aims. Its registered primary endpoint is pain measured on a 0-to-10 Visual-analog Scale from baseline to 3 months, where lower scores represent a better outcome. The registry record also reports safety counts for the Treatment Arm.
What the posted results do not provide is the primary endpoint estimate. No observed mean, full range, change, or confidence interval for pain is reported in the registry record. The absence of these results means that the magnitude and precision of any pain outcome cannot be assessed from this record. It does not establish that pain improved, worsened, or remained unchanged.
The safety entries document affected counts and serious event terms, but they do not identify the cause of each event or support a comparison with another treatment. A single-group design cannot provide a randomized between-group estimate. Even if within-group measurements were available, a change over time would not by itself separate the intervention’s contribution from other influences.
The record also does not report the analysis population, missing-data approach, or statistical plan. Therefore, it is not possible to assess the completeness of endpoint data or whether the reported analysis followed a prespecified method. The registry’s completed status describes the study status, not whether results are available for every planned outcome.
In statistical terms, this record defines a question and documents aspects of study conduct and safety reporting, but does not provide the primary outcome analysis needed to estimate pain change. The conclusions should remain limited to those recorded design details and safety entries. A result about comparative effectiveness, causal impact, or the precision of a pain estimate is not supported by the registered outcome information.
13. Why This Trial Matters Statistically
This study matters statistically because it illustrates the difference between a registered clinical question and an interpretable outcome estimate. The registry identifies postoperative pain, an intrathoracic stimulation device, and a baseline-to-3-month pain endpoint. Those details make the intended measurement understandable. Yet an endpoint definition is not a result: without observed values and an analysis, the size and precision of the outcome remain unknown.
The single-group design is also central. Feasibility studies can describe how an intervention was evaluated and can record safety information, but a one-group structure does not create a randomized treatment contrast. That distinction is important when readers encounter pre-to-post outcomes: observed change is not automatically attributable to the intervention. The registry’s allocation and model entries make clear that no like-for-like control comparison is registered.
The safety entries are another reason to read denominators and reporting context carefully. Counts among those at risk can describe what was recorded in the group, while a list of serious event terms can identify the reported categories. Neither automatically establishes causality or comparative risk. The lack of a comparator and the absence of further event-analysis details limit what can be inferred.
Finally, the record demonstrates why missing analysis details matter. Outcome populations, missing-data methods, multiplicity procedures, and the analysis plan affect how an estimate should be understood. These items are not reported in the registry record. Statistical transparency requires distinguishing what is explicitly documented from what cannot be evaluated. The posted information supports a cautious account of the design and recorded safety entries, while leaving the primary pain result unresolved.
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.
The most important trial-specific limitation in the registry record is the absence of a reported primary pain result. Although the endpoint, scale direction, and timeframe are described, no observed mean, full range, change estimate, or confidence interval is reported. The record therefore does not permit an assessment of the outcome’s magnitude or precision.
The design is single group, with allocation recorded as NA and no masking. There is no registered control arm for a like-for-like comparison. Consequently, the design cannot separate a change over time from an intervention effect using a randomized between-group contrast. This is a design limitation for causal interpretation, not a claim about what the unreported outcome would show.
Enrollment is recorded as 10, but the number included in each outcome analysis and the availability of follow-up measurements are not reported in the registry record. Missing-data handling, analysis populations, and the statistical analysis plan are also not reported. The record lists two outcome measures and zero analyses, and does not describe a multiplicity strategy.
The safety information is limited to reported at-risk and affected counts, deaths, and listed serious event terms. The registry record does not provide further detail about timing, recurrence, attribution, or the relationship between events and the device. In a single-group study, the listed counts also cannot establish comparative safety.
Finally, the record does not report a protocol-based sample-size justification. The planning assumptions described for a sample-size illustration do not establish the study’s own design rationale, and an illustrative calculation should not be interpreted as observed power. Together, these limits mean the registry supports a description of the study structure and recorded safety information, but not a quantitative conclusion about the primary pain outcome.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Feasibility Study for Intrathoracic Nerve Stimulation — NCT04066374.
- Registry record last updated 2024-07-09; status last verified 2024-06.
- Results first posted 2024-07-09.
- 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
NCT04066374 is a completed, single-group feasibility study sponsored by The Cleveland Clinic. It evaluates intrathoracic peripheral nerve stimulation for postoperative pain after cardiothoracic surgery. Enrollment is recorded as 10; allocation is NA, masking is none, and phase is NA.
The primary endpoint is pain on the Visual-analog Scale from baseline to 3 months. The scale runs from 0 for no pain to 10 for unbearable pain, with lower scores representing a better outcome. The registry record does not report the observed primary endpoint values or an analysis.
The Treatment Arm safety entries report 4 affected for serious adverse events among 10 at risk, 9 affected for other adverse events among 10 at risk, and 0 deaths. Serious event terms listed at 10.0% each include Pleural Effusion, Acute Kidney Injury, COPD, Pneumothorax, Emphysema, and Pneumonia. With no comparator group, these entries are descriptive rather than comparative.