Safety and Feasibility of a Novel Endoscopic Intervention for the Treatment of Type II Diabetes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Feasibility of a Novel Endoscopic Intervention for the Treatment of Type II Diabetes (NCT04725890), a na na study. The primary outcome is Number of Participants With Device- or Procedure-related Serious Adverse Events (SAE).

2. Clinical Question

3. Trial Design

This completed study evaluated the safety and feasibility of endoscopic application of a novel therapy for duodenal mucosal regeneration in people with type 2 diabetes. The registry describes the study as open-label and single-group. All eligible participants were to receive the DyaMX procedure; no separate control group is listed, and allocation is recorded as NA. These design features matter when interpreting the results: the record can describe outcomes among people who received the procedure, but it does not provide a concurrent comparison group for estimating what would have happened without it or under another intervention.

The planned enrollment was 65 participants. The listed intervention is the DyaMX device, classified as a device, and the study sponsor is Endogenex, Inc. The start date is 2021-04-20, the primary completion date is 2024-03-01, and the status is COMPLETED. The phase is listed as NA. The registry record does not report additional details about eligibility criteria, the procedure protocol, follow-up beyond the stated endpoint timeframe, or how the enrolled participants contributed to each analysis.

The primary outcome is the number of participants with one or more device- or procedure-related serious adverse events at 12 weeks post procedure. Secondary outcomes listed are HbA1c by post-procedure follow-up visit, fasting plasma glucose by visit, and weight by visit. The record lists 6 outcome measures and no analyses. It does not report results for the metabolic secondary outcomes or a result for the primary endpoint as defined. Separate safety summaries list serious and other adverse events, but the aggregate serious-event figure does not by itself establish how many events met the primary endpoint's device- or procedure-related criterion.

No randomized comparison is available. The registry record also does not report a sample-size justification, statistical analysis plan, or details of interim analyses. Those omissions limit what can be concluded about how the study was designed to quantify uncertainty or how its reported safety outcomes were analyzed.

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.

Before assignment: A total of 65 participants were enrolled in the study.

Overall Study

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Device- or Procedure-related Serious Adverse Events (SAE), measured over At 12 weeks post procedure.

The primary endpoint counts participants who experienced one or more serious adverse events judged to be related to the device or procedure by 12 weeks after the procedure. It is a participant count, rather than a count of every event: a participant with multiple qualifying events would still contribute once to the measure as described. The endpoint is used to describe an important safety outcome over a specified follow-up period. Its focus on seriousness and attribution makes it narrower than a count of all adverse events.

The registry record does not report a result for this endpoint. A separate safety summary reports 5 participants with serious adverse events among 65 at risk, but the summary does not establish that these events were device- or procedure-related or that each met the endpoint's timeframe and definition. The two descriptions should therefore not be treated as interchangeable. The record does not report how seriousness or relationship to the device or procedure was assessed, nor does it provide event-level details linking the safety summary to the primary endpoint.

In general, a prespecified timeframe helps define which events count toward an endpoint and supports consistent interpretation. It does not, by itself, show that all participants completed follow-up or that an event was caused by the intervention. Those details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a single-group study with no allocation and no masking. The primary measure is a count of participants with an event, while the safety summary reports the number at risk and the number affected in event categories. These are descriptive quantities: they record what was observed in the study group, rather than estimating a difference between treatment groups. The primary endpoint is explicitly limited to device- or procedure-related serious adverse events within 12 weeks post procedure.

What does a participant count mean?

General explanation: a participant count counts people meeting a definition, not the total number of episodes. If one person experiences multiple qualifying events, a participant-based measure counts that person once. This distinction matters because a count of affected participants and a count of event occurrences answer different questions. The endpoint description uses a participant count and refers to participants experiencing one or more qualifying events. The registry record does not report an event-level breakdown for that endpoint.

The separate safety data report 5 participants with serious adverse events among 65 at risk and 58 with other adverse events among 65 at risk. These broad categories should not be assumed to have the same definition as the primary endpoint. In particular, the primary endpoint requires a device- or procedure-related serious event; the aggregate serious-event count does not report that relationship. The record does not provide enough detail to reconcile the aggregate count with the endpoint definition.

Why is the study design relevant?

General explanation: a single-group design has no concurrent control arm. It can describe outcomes among participants who received the intervention, but it does not directly estimate a contrast with another intervention or with no intervention. Random allocation, when used, can help make groups comparable on average; it is not present in this study record. Because this study has no like-for-like control comparison, descriptive event counts should not be interpreted as an effect relative to a comparator.

Open-label means masking was none in the registry record. General explanation: masking can reduce the influence of expectations on some aspects of care, reporting, or assessment, depending on the outcome and procedures. The record does not explain outcome assessment methods, so the consequences of the open-label design for assessment cannot be characterized further.

How should uncertainty be understood?

General explanation: a confidence interval is a range of values that reflects statistical uncertainty under a specified method and assumptions. It helps readers distinguish a point estimate from the precision with which an underlying quantity has been estimated. No confidence interval or other uncertainty interval for the primary endpoint is reported in the registry record. It is therefore not possible to assess the endpoint's statistical precision from the record, and no interval should be inferred from the aggregate safety counts.

General explanation: counts also depend on who was observed and for how long. If follow-up is incomplete, a count among those at risk may not describe all enrolled participants in the same way as a count with complete outcome ascertainment. The record does not report participant flow, completeness of follow-up for the primary endpoint, or missing-outcome handling. The stated 12-week timeframe defines the primary endpoint window, but does not establish how many participants had complete assessment through that time.

What does the absence of listed analyses imply?

The registry record lists 6 outcome measures and no analyses. This means the record does not include analysis results or analysis-specific methods for interpreting the listed outcomes. It does not establish whether analyses were performed elsewhere. No statistical model, adjustment strategy, confidence-interval method, or hypothesis test for the primary endpoint is reported in the registry record.

The record also contains a general planning illustration assumption: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. This is a planning framework, not an observed-power calculation. The study itself is single-group, so those two-arm planning assumptions are not a description of its allocation. No numerical planning estimates or observed effect for such an illustration are reported in the record. A sample-size planning illustration cannot replace a reported endpoint result or establish the precision of the actual study findings.

Why can event classification matter?

General explanation: serious-event status, event type, and attribution to an intervention are distinct classifications. A serious event is not automatically caused by the intervention, and a listed event term does not establish causal relationship. The registry record lists several serious-event terms but does not report their relationship to the device or procedure. That missing attribution is especially consequential because the primary endpoint explicitly requires relatedness.

In general, over-dispersion matters for outcomes analyzed as counts when variability exceeds what a chosen statistical model expects. A model that fails to account for such variability can yield uncertainty estimates that are too narrow or too wide. The primary endpoint is a participant count, and the registry record reports no statistical model or analysis. There is therefore no basis for saying that an over-dispersion adjustment was or was not used.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Intervention- Non-Insulin Cohort", "Intervention- Insulin Cohort")
n      <- c(51, 14)
events <- c(0, 1)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Intervention- Non-Insulin Cohort  51  0  0.0  0.0  7.0  -0.0  7.0  0.0  6.8
ARM  Intervention- Insulin Cohort  14  1  7.1  0.2  33.9  1.3  31.5  1.7  31.9

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 6 outcome measures, including the primary safety endpoint and secondary measures of HbA1c, fasting plasma glucose, and weight. It lists no analyses. The record does not report whether hypothesis tests were planned for these outcomes, whether any adjustment for multiple comparisons was specified, or how outcomes and time points were prioritized beyond identifying the primary endpoint. The handling of multiplicity is therefore not reported in the registry record.

General explanation: when many outcomes or repeated time points are tested, the chance of at least one apparently notable finding can increase if each test is considered separately. Methods for addressing multiplicity can change how evidence is interpreted. Without a reported analysis plan or results, it is not possible to determine whether multiplicity adjustments were used or how they would affect any findings.

The record does not report the number of participants with complete primary endpoint follow-up, missing values for secondary outcomes, reasons for missing data, or methods used to handle missingness. It also does not identify analysis populations, such as whether analyses included all enrolled participants or only those with observed outcomes. These details are important for understanding which participants contribute to each estimate and how missing observations may affect interpretation.

The listed planning assumptions describe a two-arm illustration with equal allocation, while the actual study is recorded as single-group with allocation NA. The record does not report a study-specific sample-size justification or statistical analysis plan. Consequently, there is no basis in the registry record for judging whether its planned enrollment was tied to a stated precision target, how analysis populations were defined, or whether interim analyses were planned.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: colon cancer (1.5%), cerebrovascular accident (1.5%), myocardial ischemia (1.5%), pyrexia (1.5%), tonsillitis (1.5%).

The safety summary reports 5 participants with serious adverse events among 65 at risk, 58 with other adverse events among 65 at risk, and 0 deaths. These are counts of participants in the listed categories, not a complete account of every event or its timing. The record does not report event-level details or explain whether the categories overlap.

The primary endpoint is narrower than the aggregate serious-event category: it counts participants with a serious adverse event related to the device or procedure at 12 weeks post procedure. The record does not report the result for that endpoint, and it does not state that the 5 participants in the serious-event summary met the endpoint's relatedness and timeframe criteria. They should not be presented as the primary endpoint result.

The serious-event terms listed are Colon Cancer, Cerebrovascular Accident, Myocardial ischemia, Pyrexia, Tonsillitis, and Celiac Artery stenosis, each with a recorded value of 1.5%. The record does not report whether these terms were considered related to the device or procedure. General explanation: an event's occurrence during a study does not, by itself, establish that the intervention caused it. The reported 0 deaths is a descriptive count; the registry record does not provide additional detail about causes or follow-up.

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

The record establishes that the study was completed and was designed as an open-label, single-group evaluation of the DyaMX procedure. Its primary question was whether participants experienced device- or procedure-related serious adverse events by 12 weeks after the procedure. However, the registry record does not report the result for that endpoint. A separate safety summary gives broad event counts, but it does not report whether serious events were related to the device or procedure. It therefore cannot stand in for the endpoint-specific result.

The listed safety counts describe events among participants at risk: 5 participants with serious adverse events, 58 with other adverse events, and 0 deaths, each with 65 at risk in the respective summaries. The record also lists serious-event terms and their percentages. These observations provide descriptive information, but without attribution details they do not establish that the procedure caused the events. The registry record does not report event-level timing, participant-level follow-up completeness, or how the listed terms relate to the primary endpoint.

The study also lists HbA1c by post-procedure follow-up visit, fasting plasma glucose by visit, and weight by visit as secondary outcomes. Their results are not reported in the registry record. No claim about changes in glucose measures or weight can be based on the information recorded. The record gives no effect estimates, confidence intervals, or analysis results for these measures.

General explanation: a study without a concurrent control can describe outcomes in the group that received an intervention, but it cannot directly compare those outcomes with what would have occurred under another treatment or no treatment. This design also does not provide a randomized estimate of a treatment contrast. The open-label design and the absence of reported methods for outcome assessment add limits to interpretation.

Thus, the record supports a cautious description of study design and aggregate safety reporting, not a conclusion about comparative effects or metabolic outcomes. The absence of a reported endpoint result should be understood as a gap in the registry record, not as evidence that no events occurred or that an endpoint was met or not met.

14. Why This Trial Matters Statistically

This study illustrates why endpoint definitions and registry results need to be read together. The stated primary endpoint is not simply the number of serious adverse events: it is the number of participants with serious events related to the device or procedure within a specified follow-up window. The separate serious-event summary does not report that attribution. Without a result matching the primary endpoint definition, the central safety question cannot be answered directly from the registry record.

The single-group design also shapes what the data can say. Counts among people who received the procedure can describe their recorded outcomes, but there is no concurrent control group for a like-for-like comparison. General explanation: comparative treatment effects require a meaningful contrast, and a single-group observation alone cannot show how outcomes would have differed under another approach.

The study lists measures of HbA1c, fasting plasma glucose, and weight alongside the safety endpoint, but the registry record does not report results for these secondary outcomes. It also lists 6 outcome measures and no analyses. This makes the distinction between registered outcome descriptions and reported analysis results particularly important. A listed outcome is not itself evidence of an observed change or of a statistically supported finding.

Finally, the safety summary includes participant counts and serious-event terms, but limited reporting on attribution, follow-up, missing data, and analysis methods restricts interpretation. These are not merely technical details: they determine whether the broad counts correspond to the endpoint, how complete the observations are, and how precisely they estimate the outcomes of interest. The record therefore offers a useful case in separating descriptive safety reporting from endpoint-specific evidence and from comparative inference.

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.

The main limitation for interpreting the stated primary question is that its endpoint result is not reported in the registry record. The broad serious-event count cannot be assumed to match the endpoint, which requires a device- or procedure-related event within 12 weeks. The record does not report attribution details, event-level timing, or the number of participants meeting that full definition.

The study is single-group, open-label, and has no separate control arm. Its outcomes therefore do not provide a like-for-like comparison. The registry record does not describe how outcome assessment was conducted or whether any procedures were used to reduce the influence of the open-label design.

The record lists HbA1c, fasting plasma glucose, and weight as secondary outcomes but does not report their results. It also does not report confidence intervals, statistical tests, model details, or a statistical analysis plan. Although 6 outcome measures are listed, no analyses are listed, so multiplicity handling and outcome prioritization beyond the stated primary endpoint cannot be assessed.

Further details not reported in the registry record include participant flow, completion of 12-week follow-up, missing-data reasons and methods, analysis populations, event-level safety information, and the study's sample-size justification. Planned enrollment was 65, but the record does not establish how many participants contributed to every outcome or whether all planned assessments were available. These omissions constrain both the completeness and precision that can be inferred from the posted information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Safety and Feasibility of a Novel Endoscopic Intervention for the Treatment of Type II Diabetes — NCT04725890.
• Registry record last updated 2026-01-22; status last verified 2025-03.
• Results first posted 2026-01-22.
• 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

The registry record describes a completed, open-label, single-group study of the DyaMX device for endoscopic duodenal mucosal regeneration in individuals with type 2 diabetes inadequately controlled on glucose-lowering medications. Planned enrollment was 65. The study began on 2021-04-20, reached primary completion on 2024-03-01, and is listed as COMPLETED.

The primary endpoint counts participants with one or more device- or procedure-related serious adverse events at 12 weeks post procedure. Its result is not reported in the registry record. The safety summary reports 5 participants with serious adverse events among 65 at risk, 58 with other adverse events among 65 at risk, and 0 deaths, but does not establish how those counts map to the primary endpoint. HbA1c, fasting plasma glucose, and weight are listed as secondary outcomes; their results are not reported. The record lists 6 outcome measures and no analyses.