Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients (NCT02296528), a na na study. The primary outcome is Change in Upper Esophageal Sphincter (UES) Opening.

2. Clinical Question

The clinical question is whether upper esophageal sphincter opening changes after implantation of the device in this patient group. The registry also lists change in Functional Oral Intake Scale as a secondary outcome. These measures address different aspects of swallowing: the primary measure is an anatomical opening measurement, while the listed secondary measure concerns oral intake. The record does not report numerical results for either outcome, so it does not establish the direction or size of any change. Nor does it provide a comparator-based estimate of what would have happened without the device.

3. Trial Design

NCT02296528 is listed as a single-group study with enrollment of 4 and status recorded as terminated. Allocation is listed as NA, and masking as none. The official title describes the study as single-site, open-label, and phase 1; the registry phase field itself is NA. These descriptions should be kept distinct rather than treating the title’s wording as a registry phase entry.

The intervention is the Swallowing Expansion Device, described in the arm information as a titanium swallowing expansion device. The official title identifies the target population as patients with life-threatening aspiration secondary to feeding tube-dependent oropharyngeal dysphagia. The start date is 2014-06, and primary completion is recorded as 2022-10-17. The record does not give a reason for termination.

The primary outcome is change in upper esophageal sphincter opening, in millimeters, assessed before implantation and at 2 months and 2 years post implantation. The measurement description specifies fluoroscopy and a calibrated image-based distance measurement at maximum opening, with and without anterior traction of the device. Change in Functional Oral Intake Scale is listed as a secondary outcome. There are 2 outcome measures listed, while the registry reports 0 analyses.

Because this is a single-group study, observations at different time points can describe change within participants, but the design does not include a concurrent control group. The registry does not report a detailed analysis plan, a sample-size justification, interim analyses, or the reason the study was terminated. These details should not be inferred from the study title or outcome descriptions.

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

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: Population before device implantation

6. Primary Endpoint

The registry lists the primary outcome as Change in Upper Esophageal Sphincter (UES) Opening, measured over Before implantation, 2 months and 2 years post implantation.

The primary endpoint is change in upper esophageal sphincter (UES) opening, measured in millimeters. The record specifies assessment before implantation, at 2 months, and at 2 years after implantation. Fluoroscopy is used to capture a still image at maximum UES opening. The described measurement is the distance between the anterior and posterior pharyngo-esophageal segment, with the software calibrated to the known length of the visible device. Measurements are described both with and without anterior traction of the device.

This endpoint is used to quantify an anatomical feature directly related to the device’s stated mechanical purpose: opening the upper esophageal sphincter. As a continuous measure, it can be summarized using a mean and standard deviation, which are the parameter and dispersion listed for the primary outcome. General statistical context: a mean describes the average measurement in a group, while a standard deviation describes how spread out individual measurements are around that average. Neither statistic alone indicates whether a change is clinically important.

The endpoint description explains how the measurement is intended to be made, but the registry record does not report the observed means, standard deviations, or changes at the listed time points. It also does not report an estimate of uncertainty around any change. Therefore, the endpoint definition can be discussed, but its observed result and precision cannot be assessed from the posted record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: UES opening is measured in millimeters. The record specifies a mean as the summary parameter and standard deviation as the measure of dispersion. General statistical context: the mean gives a group’s average measurement, while the standard deviation describes variability among measured participants. A mean does not show the full distribution of observations, and a standard deviation is not itself a measure of uncertainty in the mean. The registry record does not post the values needed to assess either summary for this outcome.

A change outcome requires measurements at more than one time point. Here, the planned assessments are before implantation, at 2 months, and at 2 years post implantation. General statistical context: measurements from the same participant over time are related rather than independent. An analysis of repeated measurements needs to account for that relationship and specify how incomplete follow-up is handled. The registry record describes the planned time points but does not report the method used to analyze repeated observations, the number measured at each time point, or a missing-data method.

The measurement description provides procedural detail: fluoroscopy is used to capture an image at maximum UES opening, and the software is calibrated to the known length of the visible device. The distance between the anterior and posterior pharyngo-esophageal segment is then measured, with and without anterior traction. This describes the intended measurement process, not the measurement results. The record does not report information about measurement reliability, assessor training, or whether measurement assessment was blinded.

General statistical context: a confidence interval expresses the range of values compatible with the data and the statistical method used, and can communicate the precision of an estimate. The registry record does not report a confidence interval for the primary outcome. It also does not report a p-value or an inferential test for the primary or secondary outcome. Without those results, the statistical evidence for a change cannot be appraised from this record.

The registry lists 0 analyses. That entry does not establish whether analyses were or were not conducted outside the registry; it means that analysis results are not posted in the record. The analysis population is also not described. It is therefore not possible to determine whether any intended analysis included all enrolled participants, only those with follow-up measurements, or another defined group.

The study is a single-group design, and no comparator is listed. General statistical context: a within-group comparison can describe how observed measurements differ across time in the group under study. It cannot, on its own, estimate the difference between an intervention group and a concurrent control group. Nor can it rule out other explanations for changes over time. This distinction matters when interpreting any future results from this design.

The record includes a planning-illustration description based on an observed effect. It specifies a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a stated fraction of the observed effect. These are planning assumptions, not a description of the single-group trial design. No resulting participant-count values are reported in the registry record. Such illustrations are not observed power and should not be read as evidence that the study had a particular probability of detecting an effect.

General statistical context: over-dispersion means that observed variation is greater than a model’s assumptions allow. If present, it can make standard errors too small and confidence intervals too narrow unless the analysis accounts for it. The registry record does not report a model or distributional assessment for the primary outcome, so there is no basis for stating that over-dispersion was assessed or present. Similarly, the record does not describe adjustment for baseline values, covariates, or repeated measurements.

The primary outcome is one of 2 listed outcome measures, and a secondary outcome is named. The record does not report whether the analysis plan considered multiple outcomes or repeated testing, or whether any multiplicity adjustment was used. No particular statistical test, model, or adjustment procedure should be attributed to the investigators based on the information in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Swallowing Expansion Device")
n   <- c(4)
m   <- c(0.77)
sp  <- c(0.19)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Swallowing Expansion Device  4  0.770  0.190  0.468  1.072

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures: change in UES opening as the primary outcome and change in Functional Oral Intake Scale as a secondary outcome. It reports 0 analyses and does not post numerical results for either outcome. The analysis plan, including any prespecified hierarchy of outcomes or adjustment for multiple testing, is not reported in the registry record.

General statistical context: when multiple outcomes or multiple comparisons are examined, the chance of at least one apparently noteworthy result can increase if each is assessed separately without accounting for multiplicity. A prespecified strategy can help clarify how results should be interpreted. The registry does not state whether such a strategy was used, so no adjustment or unadjusted testing approach can be assumed.

Missing-data details are also not reported. The record does not give the number of participants with usable measurements at baseline or either follow-up time, reasons for missing assessments, or methods for handling missing observations. Enrollment of 4 does not establish that all 4 contributed data at every time point. It is also not reported whether the primary analysis population was defined as all enrolled participants or another group.

These omissions affect interpretation because follow-up completeness and analysis choices can influence the estimated change and its uncertainty. The record does not report a protocol-based analysis population, missing-data sensitivity analysis, or interim analysis plan. General statistical context: sensitivity analyses examine whether conclusions change under reasonable alternative assumptions, including assumptions about missing outcomes. No such results are reported in the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event entry lists the Swallowing Expansion Device group with 4 participants at risk for serious adverse events and 0 affected. It also lists 4 at risk for other adverse events and 0 affected, with 0 deaths. No serious adverse-event terms are listed. These are the posted counts and should be read as counts, not as a complete description of each participant’s clinical course.

General statistical context: safety counts describe what was recorded among the participants represented in the registry entry. With only 4 listed at risk, a count of 0 affected does not establish that an event could not occur, nor does it precisely characterize risk in a broader population. The record does not provide event narratives, timing, severity details beyond the serious/non-serious categories, or a description of safety surveillance and follow-up completeness.

The adverse-event counts do not substitute for the missing efficacy results. They also do not provide a comparison with another group, because no comparator group is listed. The reason for the study’s terminated status is not reported in the registry record and should not be inferred from the safety counts.

13. What the Result Does, and Does Not, Mean

The registry record documents a study intended to assess a mechanical swallowing device in patients with oropharyngeal dysphagia. It identifies UES opening as the primary measure and gives the planned assessment times and measurement approach. It also lists change in Functional Oral Intake Scale as a secondary outcome and posts adverse-event counts for the device group.

What the record does not provide is the primary outcome result: there are no reported means, standard deviations, changes, confidence intervals, or p-values. No numerical secondary outcome result is reported either. As a result, the record cannot establish the amount or direction of any change in UES opening or oral intake, or how precisely an effect was estimated. The absence of posted results is not evidence that no measurements were collected or that no change occurred.

The single-group design does not include a concurrent control group. General statistical context: observed changes over time in one group cannot, by themselves, identify the effect attributable to an intervention, because other influences may also vary over time. The design can describe within-group observations if results are available, but it does not supply a randomized between-group comparison.

The safety entry reports 0 participants affected by serious adverse events, 0 affected by other adverse events, and 0 deaths among 4 listed at risk in each category. These counts describe the registry entry; they do not establish safety beyond the participants and follow-up represented in it. The record does not report a reason for termination or enough detail to interpret the completeness of safety follow-up.

Overall, the posted information supports an account of the study design, planned outcome measurements, enrollment, status, and recorded safety counts. It does not support a conclusion about whether the device changed the primary outcome or about comparative effects.

14. Why This Trial Matters Statistically

This record illustrates an important distinction between a clinical question and an answer to that question. It specifies a primary endpoint, its units, measurement approach, and planned follow-up times. Those details help define what investigators intended to measure. But without posted outcome estimates, readers cannot assess the observed change or its precision.

The single-group design is also central to statistical interpretation. It can be used to describe observations over time in the enrolled group, but it does not create a concurrent counterfactual comparison. General statistical context: a controlled comparison helps separate changes associated with an intervention from changes that may occur for other reasons. The absence of a comparator should therefore shape how any available within-group result is interpreted.

The registry reports enrollment of 4 and a terminated status, alongside 0 posted analyses. Those details emphasize why study status, participant counts, outcome reporting, and analysis results need to be distinguished. Enrollment alone does not show how many participants completed each planned assessment, while a listed endpoint does not show what the measurements were.

The safety entry also demonstrates why zero counts require context. The record reports no affected participants in its listed adverse-event categories, but the number at risk is limited, and information about event timing and follow-up completeness is not reported. General statistical context: a small observed count can leave substantial uncertainty about how well the observation represents risk beyond the participants recorded.

Statistically, the record is most informative about the intended measurement framework and least informative about estimated effects. It offers no basis for evaluating the size, direction, or precision of the primary outcome change, or for comparing outcomes with an alternative intervention or no device.

15. 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 arise from the specific registry record. Enrollment is 4, and the design is single-group, with no comparator listed. The official title describes the study as single-site and open-label, while the registry records masking as none. The registry phase field is NA even though the official title calls it a phase 1 human trial; the record does not resolve that difference.

The study status is terminated, but the reason is not reported in the registry record. The record does not state whether the planned follow-up assessments were completed, how many participants contributed measurements at each time point, or whether all enrolled participants were included in any analysis. It reports 0 analyses and provides no numerical primary or secondary outcome results.

The primary outcome description is detailed about the intended fluoroscopic measurement, but measurement reliability and assessor blinding are not reported. The analysis method for the continuous endpoint, approach to repeated observations, missing-data handling, and treatment of multiple outcomes are also not reported in the registry record. No protocol-based sample-size justification or interim analysis plan is reported.

These omissions make it impossible to assess the size and precision of an observed change, the completeness of follow-up, or the influence of analysis choices. The single-group design would also limit causal interpretation even if within-group results were available. The posted safety counts are limited to the listed categories and do not include event narratives or details about surveillance duration.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients — NCT02296528.
• Registry record last updated 2026-04-20; status last verified 2023-12.
• Results first posted 2026-04-20.
• 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.

19. Record Summary

NCT02296528 is a terminated, single-group study of the Swallowing Expansion Device, with enrollment recorded as 4. The official title describes a single-site, open-label, phase 1 human trial; the registry phase entry is NA. The start date is 2014-06, and primary completion is recorded as 2022-10-17.

The primary outcome is change in UES opening in millimeters, measured before implantation, at 2 months, and at 2 years post implantation. Change in Functional Oral Intake Scale is listed as a secondary outcome. The registry reports 2 outcome measures and 0 analyses, and does not post numerical results for either outcome.

The adverse-event entry lists 4 at risk for serious events and 0 affected, 4 at risk for other events and 0 affected, and 0 deaths. The reason for termination, missing-data methods, analysis population, and statistical analysis plan are not reported in the registry record.