Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy (NCT04299425), a randomized na study. The primary outcome is Average Number of Parathyroid Glands Identified With High Confidence Per Patient.

2. Clinical Question

The comparison concerns a method for recognizing glands during surgery, rather than a long-term clinical outcome. The primary endpoint captures the average count of glands identified with high confidence in each study arm. The trial also registered outcomes relating to persistent hyperparathyroidism or hypercalcemia, procedure duration, hospital stay, false-positive excised tissues, frozen sections, and repeat surgery. Results for some of these outcomes are not reported in the registry record.

3. Trial Design

The registry record describes a randomized, single-blinded, parallel-group trial at a single center. The recorded enrollment is 160. The two groups each have 80 participants for the primary endpoint: one group used PTeye near-infrared autofluorescence detection as an adjunct to naked-eye identification, and the other relied on naked-eye identification without the device. The record lists the phase as not applicable and gives the trial status as completed.

The listed intervention is a device-based detection technology. The registry record describes the study as evaluating the clinical benefits of using an FDA-cleared PTeye device for identifying parathyroid glands during parathyroidectomy. The meaning of single-blinding—such as which participants or study personnel were unaware of group assignment—is not reported in the registry record. Further details of sequence generation, concealment of assignments, or implementation of randomization are also not reported in the registry record.

The recorded study start date is 2020-03-13, and the primary completion date is 2023-03-03. The primary endpoint is measured immediately during the parathyroidectomy procedure. Follow-up windows vary across secondary outcomes: persistent hyperparathyroidism or hypercalcemia is specified at 6 months after surgery, and repeat parathyroidectomy is listed at 6-months post-operation. Enrollment, outcome timing, and follow-up descriptions should be read as registry information; details about recruitment flow and completeness of follow-up are not reported in the registry record.

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.

6. Primary Endpoint

The registry lists the primary outcome as Average Number of Parathyroid Glands Identified With High Confidence Per Patient, measured over Immediate. During PTx procedure..

The primary endpoint is the average number of parathyroid glands identified with high confidence per patient during the parathyroidectomy procedure. The record describes the intervention group’s count as glands identified with the naked eye plus near-infrared autofluorescence, and the comparison group’s count as glands identified with the naked eye. The measure is a mean, with standard deviations reported for each group.

This endpoint is used to quantify gland identification during the operation, which is the immediate task the device is intended to assist. A group mean gives the average count across participants, while the standard deviation describes how much individual counts vary around that mean. The endpoint does not, by itself, measure whether identified tissue was subsequently confirmed as a parathyroid gland, whether the operation achieved a lasting biochemical result, or whether patients avoided further procedures. Those questions relate to other outcomes, and their results must be considered separately.

The primary endpoint is measured during surgery rather than at a later follow-up visit. It therefore provides an immediate measure of identification activity, not a direct measure of long-term health. The registry record does not report further operational details about how high-confidence identification was defined or assessed.

7. Results Posted in the Registry

• NIRAF Detection Technology -: mean 2.70 versus 3.10 on control; difference -0.40 (95% CI -0.76 to -0.04), standardized effect d = -0.34; z-test p = 0.031.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy).

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • NIRAF Detection Technology -: 1.2% (1/80) versus 0.0% (0/80) on control; risk difference 1.2 percentage points (95% CI -1.2 to 3.7); unadjusted two-proportion z-test p = 0.316.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NIRAF Detection Technology - and the control. The interval gives the range of effects that remain compatible with the data.

Duration of Parathyroidectomy (PTx) Procedure

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • NIRAF Detection Technology -: mean 95.50 versus 89.30 on control; difference 6.20 (95% CI -5.06 to 17.46), standardized effect d = 0.17; z-test p = 0.280.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NIRAF Detection Technology - and the control. The interval gives the range of effects that remain compatible with the data.

Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • NIRAF Detection Technology -: 2.0% (1/50) versus 0.0% (0/51) on control; risk difference 2.0 percentage points (95% CI -1.9 to 5.9); unadjusted two-proportion z-test p = 0.310.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NIRAF Detection Technology - and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the question beyond immediate gland identification to include biochemical persistence, procedure duration, hospital stay, false-positive excisions, frozen sections, and repeat surgery. The overall pattern is not a uniform set of differences favoring one group across these distinct types of outcomes. The posted results include continuous and event-count measures, and the limited event counts mean that some comparisons carry substantial uncertainty.

These outcomes relate to the primary finding in different ways. Procedure duration measures an aspect of the operation, while later biochemical outcomes and repeat surgery address follow-up events. A difference in the primary identification count does not necessarily entail a difference in any of those outcomes. Conversely, secondary outcomes do not directly validate or invalidate the immediate identification measure. The registry lists six secondary outcome measures, but results for some are not reported in the registry record.

Unadjusted secondary comparisons carry less weight when several outcomes are examined. As a general statistical point, testing multiple outcomes increases the chance of finding an apparently notable result by chance if each is assessed separately without an adjustment or a pre-specified hierarchy. The registry record does not report a multiplicity adjustment or explain how secondary outcomes were prioritized. The secondary findings are therefore best treated as supporting context rather than as a set of independent confirmatory conclusions.

Denominators and measurement times also differ across outcomes. The primary endpoint and some secondary measures have 80 participants per arm, while the posted repeat-procedure outcome uses smaller arm denominators. The reasons for those differences and the completeness of follow-up are not reported in the registry record. This makes it important to consider each endpoint’s population and timing rather than assume that every secondary result represents the same complete group of participants.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy).
• Number of Frozen Sections Sent for Analysis
• Duration of Parathyroidectomy (PTx) Procedure
• Number of Participants Stratified by Duration of Hospital Stay
• Number of 'False Positive' Tissues Excised by Surgeon
• Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous: each participant contributes a count of glands identified with high confidence, and the registry reports the group mean and standard deviation. A mean describes the central average across a group. A standard deviation describes participant-to-participant spread in the measured values; it is not the uncertainty of the group mean. The primary results give means of 3.1 and 2.7 and standard deviations of 1.21 and 1.13, respectively.

What does the mean difference express?

The posted recalculation compares the naked-eye group with the PTeye group. Its mean difference is -0.4. The sign depends on the order of subtraction: a negative value means the first group in that contrast has a lower observed mean than the reference group. The two arm means are useful for understanding the direction, while the difference expresses the contrast on the endpoint’s original scale, parathyroid glands. This is an unadjusted comparison based on the posted group summaries, not an estimate adjusted for participant characteristics or other variables.

What does a two-sided t-test assess?

The registry reports a two-sided t-test for the primary comparison. In general, a two-sided test assesses evidence against equality in either direction, rather than testing only whether one specified group is higher. The test produces a p-value under a null model in which the groups have no difference in their means. A p-value describes how unusual results at least as incompatible with that model would be if the model and test assumptions held. It is not the probability that the null model is true, nor is it a measure of clinical importance.

As a general statistical matter, a t-test for independent groups relies on assumptions about independent observations and the behavior of the outcome or its sampling distribution. There are different forms of t-test, including versions that do not assume equal group variances. The registry record identifies a two-sided t-test but does not report which specific form was used, diagnostic checks, transformations, or any adjustment for covariates. The recalculated summary-statistic comparison is unadjusted.

How should standard errors and standard deviations be distinguished?

As a general explanation, a standard deviation describes dispersion among individual observations, whereas a standard error describes the sampling uncertainty of an estimated quantity such as a mean. The registry gives standard deviations for the primary arm summaries. The posted recalculation also contains standard errors for the two group means, but those are not separate clinical outcomes. They help describe the precision of the mean estimates and depend on the variability and number of observations in each group.

What can the interval add?

A confidence interval gives a range of values compatible with the data and the calculation method at a stated confidence level. In repeated use of a method, intervals constructed in that way have a coverage interpretation under the method’s assumptions. The confidence level for the posted primary interval is not reported in the registry record, so it should not be assigned a particular level from the record alone. The interval’s location relative to zero is still informative about the range of contrasts represented by the calculation, but does not remove uncertainty or establish a clinical conclusion.

What is the role of the recalculation?

The recalculated contrast uses the posted group means, standard deviations, and sample sizes to make a simple unadjusted comparison. It is not a reconstruction of every detail of the sponsor’s analysis. The sponsor’s own reported primary analysis is a two-sided t-test with p = 0.04; the unadjusted recalculated p-value is 0.031. These are distinct reported values and should be kept distinct. The registry does not give the sponsor’s test statistic, degrees of freedom, model details, or a confidence interval for its analysis. The record does not flag a discrepancy between the sponsor analysis and the recalculation.

General statistical interpretation also depends on what was planned in advance, how missing observations were handled, and which participants were included in each analysis. Those details are not reported in the registry record. Randomization supports a group comparison in principle, but it does not by itself resolve questions about departures from assigned treatment, missing data, outcome measurement, or multiplicity across endpoints. Those uncertainties limit how much can be inferred from a p-value alone.

11. Confidence Intervals and Precision

The primary recalculated mean difference is -0.4 for the naked-eye group relative to the PTeye group. Its posted interval runs from -0.763 to -0.037; to keep displayed values to three decimal places, the endpoints are -0.763 and -0.037. The interval lies on one side of zero, so the recalculated range does not include no difference under the calculation used. The confidence level for this interval is not reported in the registry record.

An interval communicates uncertainty around an estimate rather than a guarantee that the true effect falls within the displayed limits. In general, a narrower interval indicates greater precision, while a wider interval allows a broader range of effects. Precision depends on factors including sample size and variability, and the interval should be interpreted in the context of the outcome scale and the study design. The primary group standard deviations indicate that participants’ observed counts varied within both arms; the mean difference is an average contrast and does not describe every participant’s result.

The interval’s position relative to zero is not enough to determine whether the magnitude matters in practice. The registry record does not report a threshold defining a meaningful difference in the number of high-confidence identifications. Nor does it provide the confidence level or a sponsor-reported interval for the primary analysis. Consequently, the posted recalculated interval supports interpretation of the summary-data contrast but cannot fill in those unreported design and analysis details.

Intervals for secondary outcomes also represent uncertainty, and sparse event counts can make estimates particularly uncertain. The secondary results should be read as separate, exploratory evidence rather than as confirmation of the primary endpoint. The registry record does not report a plan for adjusting intervals or tests across the multiple outcomes.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for 80% power and participants per arm for 90% power. They are not total sample sizes and do not represent the number of participants actually observed. For this continuous-outcome calculation, the stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to be detected is set to a stated fraction of the observed effect.

The 80% power column describes the planning sample size that, under those assumptions and for the selected target effect, would give an 80% chance of detecting an effect at the stated significance level if that effect were the true one. The 90% column uses a higher target chance of detection and therefore calls for more participants under the same assumptions. These are planning probabilities under a model, not guarantees for a future study.

The planning illustrations use the observed contrast as one possible target and also consider smaller fractions of that contrast. When the target effect is smaller, separating it from background variation is harder, so more participants are required. The planning assumptions are not the original trial’s design assumptions; those original assumptions are not reported in the registry record. These figures are not observed power: they are hypothetical planning illustrations based on the observed effect and stated calculation assumptions.

Because the calculation uses the observed effect, it should not be read as evidence that the trial was adequately or inadequately designed. The observed estimate itself is uncertain, and a planning exercise built around it inherits that uncertainty. The displayed figures are most useful for understanding how sample-size requirements change when the target effect and desired power change, not for judging the trial’s result after completion.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.400; pooled standard deviation σ = 1.171.
2. n = 2 × (1.96 + 0.842)² × 1.171² / -0.400² = 134.5, rounded up to 135 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.4                      # observed difference in means
sigma <- 1.17068356100186                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4299425)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 135 (80% power), 181 (90% power)
 75% of observed effect: n per arm = 240 (80% power), 321 (90% power)
 50% of observed effect: n per arm = 538 (80% power), 721 (90% power)
power.t.test: 135.4 
Simulated power at n = 135 per arm: 0.801 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports the sponsor’s primary analysis as a two-sided t-test, with p = 0.04 and a superiority label. The unadjusted recalculation from the posted means, standard deviations, and group sizes gives p = 0.031. The recalculation also provides a mean-difference estimate and interval derived from the posted summary statistics. The registry record does not give an estimate, confidence interval, test statistic, or further model details for the sponsor’s analysis.

The record does not flag a discrepancy between the sponsor analysis and the recalculation. The two p-values should still be described as separate results: the sponsor-reported value is the result of the sponsor’s analysis, while the recalculated value comes from a simple unadjusted comparison of posted summaries. They are close but not identical, and the registry does not explain the difference. It would be inappropriate to attribute that difference to a particular modeling choice or data-handling decision without further information.

The sponsor’s reported analysis is the appropriate account of the sponsor’s own test. The recalculation is useful as a transparent check based on the posted group summaries, but it does not replace an analysis plan or participant-level analysis. Neither p-value alone describes the size or practical importance of the observed contrast.

15. Multiplicity, Missing Data and Analysis Populations

The registry includes a primary endpoint and multiple secondary outcomes. Examining several outcomes raises the general issue of multiplicity: if each comparison is tested separately, the chance of at least one apparently unusual result can increase. Statistical approaches can address this issue through pre-specified outcome hierarchies, adjusted significance thresholds, or other procedures. Which, if any, were used for this trial is not reported in the registry record. The record also does not report whether secondary analyses were designated as confirmatory or exploratory.

Information about missing observations and analysis populations is limited. The registry record does not report how missing primary outcome data were handled, whether analyses followed intention-to-treat principles, whether participants were analyzed according to assigned group, or whether any per-protocol or safety populations were defined. It also does not report participant flow, reasons for withdrawal, protocol deviations, or imputation methods. These details matter because results can depend on who contributes data and how incomplete observations are treated.

Some posted outcomes use different denominators from the primary endpoint. The repeat-parathyroidectomy results are reported for 51 participants in one arm and 50 in the other, rather than the primary endpoint’s 80 per arm. The reason for these denominators is not reported in the registry record. For other outcomes, the record gives different measurement windows, including an immediate intraoperative assessment and follow-up at 6 months. The timing and available participants should therefore be considered outcome by outcome.

The registry record does not report interim analyses, stopping rules, or a detailed statistical analysis plan. It also does not explain how the single-blinding was implemented or whether outcome assessors were blinded. These omissions do not show that a procedure was absent; they mean those details are not reported in the registry record. Without them, it is not possible to determine from the record alone how the analysis addressed multiplicity, missingness, deviations from assignment, or other pre-specified analysis decisions.

16. 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 reports zero serious adverse events among 80 participants in the PTeye group and zero among 80 participants in the naked-eye group. It also reports zero other adverse events in each group and zero deaths in either group. These are the posted event counts for the groups and categories recorded in the registry.

Zero reported events should be interpreted as an observation in this trial, not as proof that no adverse events can occur. Event counts provide limited information about uncommon outcomes, particularly when the number of participants is finite. The record does not provide a list of serious adverse event terms, and it does not report further details on event collection, definitions, monitoring, or follow-up completeness. The figures therefore describe what was recorded, while leaving uncertainty about the broader safety profile and events outside the reported observation period.

The adverse-event summaries are separate from the primary effectiveness endpoint. They do not establish the balance of all possible benefits and harms, and they do not support medical advice. They should be considered alongside the trial’s design, follow-up, and reporting limitations.

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

The primary result is an observed difference in the average number of parathyroid glands identified with high confidence during surgery. The PTeye group’s mean was 3.1, compared with 2.7 in the naked-eye group. The recalculated contrast, written as naked-eye relative to PTeye, is -0.4, with an interval from -0.763 to -0.037 when rounded to three decimal places. The sponsor’s reported two-sided test gives p = 0.04, while the unadjusted recalculation gives p = 0.031.

These statistics describe the measured endpoint in the trial groups. They do not establish that every participant had more glands identified, or that the device changed outcomes beyond the immediate identification measure. The registry record does not report a threshold for a clinically important difference, so the practical importance of the observed mean contrast cannot be determined from the statistical result alone.

The primary endpoint is not itself a measure of persistent hyperparathyroidism, hypercalcemia, surgical complications, hospital stay, or repeat surgery. Those outcomes are registered separately, and their results are incomplete in the record. A statistical difference in an intraoperative measure should not be treated as proof of a difference in later outcomes. Likewise, a lack of a clear distinction in a secondary comparison would not erase the observed difference in the primary measure.

Randomization is intended to support a fair comparison of assigned groups, but the registry record does not provide enough detail to assess all implementation and analysis decisions. Information about blinding, missing data, analysis populations, and multiplicity is not reported in the registry record. The result should therefore be understood as an estimate from this completed single-center trial, with uncertainty around its magnitude and limitations in what the available outcomes can establish.

18. Why This Trial Matters Statistically

This trial raises a statistical question common in procedural research: how should an immediate technical measure be connected to outcomes that matter later? The primary measure counts high-confidence gland identifications during surgery. It is close to the intended function of the detection approach, but it is not interchangeable with longer-term biochemical outcomes or the need for another operation. Keeping these outcome types distinct helps prevent an immediate process measure from being interpreted as a complete account of clinical benefit.

The randomized, parallel-group design supports a direct comparison of two identification approaches. The primary endpoint is reported with group means and standard deviations, allowing the average contrast and its uncertainty to be examined. The posted recalculation makes the direction of the contrast explicit, while the sponsor-reported test offers a separate account of the primary analysis. Reading both estimates and tests together is more informative than relying on a single p-value.

The trial also illustrates why precision and reporting details matter. The primary contrast is accompanied by an interval, but the interval’s confidence level is not reported in the registry record. Details about missing data, analysis populations, multiplicity, and the implementation of blinding are also not reported. These are not merely technical footnotes: they help readers understand how robustly the observed summaries represent the intended comparison.

Finally, sparse secondary events and different follow-up denominators show why absence of a clear secondary pattern cannot be treated as proof of equivalence. A trial can estimate an immediate endpoint more precisely than uncommon later events. Statistical interpretation therefore depends on the particular endpoint, its scale, follow-up, uncertainty, and analysis—not on a single conclusion applied across every outcome.

19. 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 trial is described as single-center, which limits how directly its findings can be generalized to settings with different surgical teams, workflows, or patient populations. The registry record does not report detailed eligibility criteria or the characteristics of enrolled participants, so the degree to which the participants represent a broader population cannot be assessed from this record.

The primary outcome is an intraoperative count of glands identified with high confidence. The registry record does not report the operational definition of high confidence, how identification was verified, or whether outcome assessment was blinded. Single-blinding is recorded, but the identity of the blinded party is not reported in the registry record. These details matter for an outcome involving recognition during a procedure.

Several analysis details are also not reported in the registry record, including the original sample-size justification, the detailed statistical analysis plan, missing-data handling, analysis populations, interim analyses, and multiplicity procedures. The sponsor’s primary p-value and the recalculated p-value are not identical, and the record does not explain the difference. The recalculation is based on posted summary statistics and is not a substitute for participant-level analysis.

Secondary outcomes vary in type and follow-up, and some registered outcomes have no results reported in the registry record. The repeat-surgery outcome has smaller denominators than the primary endpoint, with no explanation of the difference. Event counts for safety outcomes are zero in the reported categories, but the registry does not provide detailed event terms or information about ascertainment. These reporting limitations constrain interpretation of longer-term outcomes and uncommon events.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy — NCT04299425.
• Registry record last updated 2024-05-13; status last verified 2024-04.
• Results first posted 2024-05-13.
• 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.

23. Record Summary

NCT04299425 is a completed, randomized, single-blinded, parallel-group, single-center trial evaluating near-infrared autofluorescence detection with the PTeye device during parathyroidectomy. The recorded enrollment is 160, with 80 participants per arm for the primary endpoint.

The primary outcome is the average number of parathyroid glands identified with high confidence per patient during surgery. The posted means are 3.1 with PTeye and 2.7 with naked-eye identification alone. The registry reports a two-sided sponsor analysis with p = 0.04; the unadjusted recalculation gives p = 0.031 and a mean difference of -0.4 for naked-eye relative to PTeye.

Secondary outcomes address procedural and follow-up measures, but results for some registered outcomes are not reported in the registry record. Further details about the statistical plan, missing data, analysis populations, and blinding implementation are also not reported in the registry record.