T-GENVIH-003 LTFU (Long Term Follow Up) Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for T-GENVIH-003 LTFU (Long Term Follow Up) Study (NCT06034652), a registered phase not stated study. The primary outcome is Number of Participants With Clinically Confirmed Recurrence.

2. Clinical Question

3. Trial Design

T-GENVIH-003 LTFU is a prospective follow-up study of Gentrix® Surgical Matrix used for reinforcement in ventral hernia repair. Its stated purpose is to collect additional, longer-term performance data from a subset of participants in the earlier T-GENVIH-002 study. The subset is described as the twenty-one cases with a minimally invasive surgical approach, meaning laparoscopic or robotic repair.

The registry reports enrollment of 8. The listed group is a prospective analysis of people with a prior minimally invasive approach; no parallel control group or randomized allocation is described. The record specifically cautions that the arms are not a like-for-like control comparison, and allocation is not stated. The listed device is Integra® Gentrix® Surgical Matrix. The description concerns follow-up after the earlier repair, from its last data-collection point at 1-yr post-op to the present study.

The study started on 2023-09-12, had primary completion on 2024-01-19 and is listed as COMPLETED. The primary outcome timeframe is through study completion, an average of 4 months. The registry defines the Intent-to-Treat population as all enrolled subjects who provide an informed consent waiver and receive the study intervention. Further details about recruitment, retention, or the timing of individual participants’ assessments are not reported in the registry record.

Because this is follow-up of a subset from an earlier study rather than a controlled treatment comparison, the design can describe outcomes in the enrolled group but cannot isolate the effect of the device from other explanations. The record does not report a protocol rationale for the enrollment or a statistical design justification.

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: Non-applicable.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention.

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: Statistical Analysis will be based on data from all evaluable subjects meeting the eligibility criteria.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Clinically Confirmed Recurrence, measured over Through study completion, an average of 4 months..

The primary endpoint is the number of participants with clinically confirmed recurrence of the primary hernia. It is a count of participants with an event, rather than a continuous measurement such as a score or a measurement of change. The registry describes the event as recurrence to date, including recurrence not previously reported in T-GENVIH-002. The timeframe is through study completion, with an average of 4 months.

Clinically confirmed recurrence focuses on whether the repaired hernia has recurred according to clinical confirmation. This is distinct from a participant’s self-reported recurrence, which is listed among the secondary outcomes. In general, prespecifying a primary endpoint gives a study a main outcome to assess and helps readers distinguish it from additional outcomes. The registry does not report further details about how recurrence was clinically confirmed or adjudicated.

The endpoint is defined, but its observed count is not reported in the registry record. Without that count and its applicable denominator, the primary outcome cannot be described quantitatively from this record. The listed follow-up timeframe also matters when interpreting the endpoint: it describes recurrence assessed through study completion, not an unspecified longer period.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of outcome is being counted?

The primary endpoint is a binary event at the participant level: a participant either has clinically confirmed recurrence or does not, under the study’s endpoint definition. The registry reports the endpoint as a number of participants with the event. In general, binary outcomes are often presented as event counts alongside the number of participants assessed. Those quantities allow readers to understand the observed frequency and the amount of information behind it. The recurrence count and endpoint-specific denominator are not reported in the registry record.

A count is not itself a rate or a risk estimate. To interpret a proportion, the numerator and the relevant denominator must refer to the same outcome and assessment population. It would not be appropriate to use enrollment automatically as the denominator for an endpoint if the number assessed is not known. The registry defines an Intent-to-Treat population, but does not report how many participants contributed data to the primary endpoint.

What would uncertainty mean?

In general, an estimate from a group is subject to sampling uncertainty: another comparable group could produce a different observed count. A confidence interval is a way of expressing the range of values compatible with the data under the method’s assumptions. A small amount of information, especially when events are uncommon, can leave substantial uncertainty even when the observed event count is zero. No confidence interval for recurrence is reported in the registry record, and none can be interpreted without the endpoint data and an appropriate analysis.

The registry’s primary outcome is a participant count, not a time-to-event endpoint. The stated timeframe is through study completion, with an average of 4 months. The record does not report participant-level follow-up durations or an analysis accounting for different observation times. Therefore, the outcome should not be recast as a rate per unit of time or interpreted as a survival estimate.

What analyses are reported?

The registry record lists 0 analyses. It does not report a statistical comparison for the primary outcome, an adjusted estimate, a confidence interval, or a p-value. The record also does not report a statistical analysis plan, any covariate adjustment, or an interim analysis. Their absence from the record means these methods cannot be assumed to have been used.

In general, statistical tests and intervals depend on their assumptions and on the design. For a single follow-up group, a descriptive estimate would address the observed outcome in that group. A comparison between groups would require appropriate comparison data and a design or analysis that makes the groups meaningfully comparable. The registry cautions that the arms are not a like-for-like control comparison and does not state an allocation method. It would therefore be misleading to interpret the study as a randomized estimate of a treatment effect.

How should the planning illustrations be read?

The stated assumptions describe planning illustrations based on the observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These assumptions concern planning scenarios; they are not evidence that the completed follow-up study used two randomized arms or that it had a particular achieved power. Sample-size illustrations are not observed power.

The distinction is important because a planning calculation asks what sample size could be needed under chosen assumptions, while an analysis of completed data estimates an outcome from what was observed. The registry does not report the study’s own sample-size justification. The values used for the observed effect and the resulting planning estimates are not reported in the registry record. The planning assumptions cannot fill in the missing primary outcome result.

What does a count of zero establish?

For serious adverse events, the registry lists 0 affected among 8 at risk. This means no serious adverse event was recorded in that group according to the posted figures; it does not prove that the chance of an event is zero. In general, when no events are observed in a limited group, the data can still be compatible with a range of underlying event probabilities. The precision of an estimate depends on the amount of relevant information and the method used. No interval estimate is reported for these safety figures.

These general concepts explain how counts, estimates and uncertainty are ordinarily interpreted. They do not establish which statistical procedures were actually used for T-GENVIH-003. The registry does not report an inferential analysis for the listed outcomes, so the descriptive safety counts should remain distinct from any unreported statistical estimate.

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("Prospective Analysis of Minimally Invasive Surgica")
n      <- c(8)
events <- c(2)
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  Prospective Analysis of Minimally Invasive Surgica  8  2  25.0  3.2  65.1  7.1  59.1  7.5  60.0

11. Multiplicity, Missing Data and Analysis Populations

The registry identifies clinically confirmed recurrence as the primary outcome and lists secondary outcomes concerning self-reported recurrence, surgical site occurrences requiring procedural intervention, surgical site occurrences, and surgical site infections. These outcomes address different aspects of recurrence and postoperative events. The record does not report results for the listed secondary outcomes.

When a study evaluates multiple outcomes, the chance of at least one apparently notable result can increase if each outcome is tested separately. In general, a multiplicity strategy may define which outcomes are confirmatory, adjust testing, or treat secondary findings as exploratory. No multiplicity approach or hierarchy for testing outcomes is reported in the registry record. Since the record lists 0 analyses, it does not provide a set of reported tests from which to assess multiplicity handling.

Missing-data methods are also not reported in the registry record. The description identifies an Intent-to-Treat population as enrolled subjects who provide an informed consent waiver and receive the study intervention, but does not state how participants with unavailable follow-up or an unassessed outcome were handled. The number assessed for the primary endpoint and reasons for any missing outcome data are not reported.

These omissions limit interpretation. If outcome availability differed among participants, a count among those assessed could differ from the result for all enrolled participants. In general, transparent reporting of the analysis population, missingness and the method used to handle missing outcomes helps readers judge whether a result may be affected by incomplete follow-up. The registry record does not provide those details for the primary or secondary outcomes.

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 registry’s serious adverse event figures list 8 participants at risk, 0 affected and 0 deaths for the prospective analysis group. The other adverse event fields also list 8 at risk and 0 affected. No serious adverse event terms are listed. These are the posted counts for this group, not a comparison with another treatment or control group.

A count of 0 means that no affected participants or deaths were recorded in the listed figures. It does not mean that the true risk is zero. In general, rare events may not appear in a limited group, and the observed count alone cannot establish the frequency of events in a broader population. The registry does not report an uncertainty interval for these counts.

The serious adverse event figures should also be kept separate from the primary recurrence outcome. The recurrence count is not reported in the registry record, and the safety figures do not substitute for it. The record does not describe further methods for adverse event collection or attribution. Consequently, these figures support a narrow description of the posted safety counts, not a broad conclusion about comparative safety.

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

The record documents a prospective long-term follow-up study of Gentrix® Surgical Matrix in ventral hernia repair, with enrollment of 8 and a primary endpoint defined around clinically confirmed recurrence. It also records serious adverse event figures of 0 affected among 8 at risk and 0 deaths for the listed group. These are descriptive elements of the registry record.

The primary recurrence result itself is not reported in the registry record. Nor are the values for the listed secondary outcomes. Without these outcome results, the record cannot show how many participants had recurrence or other listed events, and it cannot establish the precision of those outcomes. There is no reported inferential analysis to support a treatment-effect estimate.

The study’s design also sets limits on what could be concluded. It follows a subset of participants from an earlier study and is not described as a randomized comparison. The registry cautions that the arms are not a like-for-like control comparison. An outcome observed in this group would describe the group’s experience, but by itself would not separate the device’s contribution from other influences or establish what would have happened under another treatment.

In general, the absence of a recorded event is not proof that an event is impossible, and the absence of a reported result is not evidence of no effect. The figures should not be used to claim that the device works or does not work. They support a limited account of the study’s stated question, enrollment and posted safety counts, while leaving the primary outcome and its uncertainty unresolved.

14. Why This Trial Matters Statistically

This study is statistically relevant because it illustrates the difference between defining an outcome and reporting a result. The registry gives a specific primary question—clinically confirmed recurrence—but the observed count is not reported in the registry record. Without the count and the number assessed, readers cannot quantify that outcome or judge its precision.

It also illustrates why design matters when interpreting follow-up data. T-GENVIH-003 is described as a prospective analysis of a subset from T-GENVIH-002, not as a randomized treatment comparison. The registry does not state allocation and explicitly cautions against treating the arms as like-for-like controls. Descriptive follow-up can be informative about what was recorded in the enrolled group, but it does not by itself establish a comparative treatment effect.

The posted safety figures provide another useful distinction: observing 0 serious adverse events in the listed group is not the same as showing that the underlying risk is zero. General statistical reasoning requires attention to the amount of information and the uncertainty around an estimate, especially when events may be uncommon. No interval estimate is reported for these safety counts.

Finally, the planning assumptions should not be confused with the completed study’s analysis. The registry describes planning illustrations using a two-sided significance level of 0.05, equal allocation between hypothetical arms and a normal approximation. These calculations are planning illustrations, not observed power, and they do not establish the rationale for the study’s enrollment. The record does not report its own sample-size justification or a statistical analysis plan.

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 specific to this record constrain interpretation. Enrollment is 8, while the study description refers to a subset of twenty-one minimally invasive cases from T-GENVIH-002. The record does not explain the difference between the subset described and the number enrolled in this follow-up study, so selection into follow-up and the representativeness of the enrolled group cannot be assessed from the record.

The study is not described as randomized, allocation is not stated, and the registry cautions that the arms are not a like-for-like control comparison. As a result, the record does not support a controlled estimate of the device’s effect. The primary recurrence count and secondary outcome values are not reported in the registry record, and no inferential analyses are listed.

The primary timeframe is through study completion, described as an average of 4 months. The record does not report individual follow-up durations, the number assessed for recurrence, or whether all enrolled participants completed outcome assessment. Missing-data handling, outcome confirmation procedures and the statistical analysis plan are also not reported in the registry record.

The posted serious adverse event figures are descriptive and come from a limited group; they cannot establish that serious events do not occur. The record does not report uncertainty intervals for those counts. Finally, it does not report the study’s sample-size justification or a multiplicity strategy for the several listed outcomes. These limitations mean that the registry record offers a narrow account of the study design and safety counts, rather than a complete quantitative evaluation of its stated performance question.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: T-GENVIH-003 LTFU (Long Term Follow Up) Study — NCT06034652.
• Registry record last updated 2025-05-20; status last verified 2025-05.
• Results first posted 2025-05-20.
• 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

NCT06034652, titled T-GENVIH-003 LTFU, is a completed prospective follow-up study sponsored by Integra LifeSciences Corporation. It concerns longer-term performance data for Integra® Gentrix® Surgical Matrix used for soft tissue reinforcement in ventral hernia repair, following minimally invasive repairs in the earlier T-GENVIH-002 study. The study started on 2023-09-12, had primary completion on 2024-01-19, and reports enrollment of 8.

The primary endpoint is the number of participants with clinically confirmed recurrence through study completion, with an average timeframe of 4 months. The observed primary outcome and the listed secondary outcome values are not reported in the registry record. The listed safety figures show 0 serious adverse events among 8 at risk and 0 deaths. The record does not report statistical analyses, a sample-size justification, missing-data methods or a multiplicity approach. The study is not described as a randomized comparison, and its arms are not identified as like-for-like controls.