Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System (NCT03096483), a na na study. The primary outcome is Imaging Guidance Adequacy Assessed by Number of Questionnaires.

2. Clinical Question

Statistically, the question is descriptive: what investigator-reported adequacy information was collected during use of the device in these procedures? Without a comparison group or reported outcome estimate, the registry record cannot establish whether the questionnaire result differed from another device, a prior approach, or a prespecified benchmark. The instrument's response options and the meaning of an adequate rating are not reported in the registry record.

3. Trial Design

This was a single-group device study of the OEC Elite system. The registry lists enrollment of 12 and one arm, the OEC Elite Imaging Arm. That arm included vascular, gastrointestinal (GI), urology or pain management procedures for which the system was used. No separate control arm is described, and allocation is listed as NA. Masking is listed as NONE. The record labels the phase NA.

The study's brief summary says its purpose was to collect survey data on use of the OEC Elite Mobile Fluoroscopy System based on routine clinical use. This differs from a randomized efficacy comparison: the registry does not describe assignment to competing interventions, a control condition, or a masked assessment. The design can describe recorded experience in the enrolled group, but it does not by itself distinguish device-related effects from other influences on procedure completion or investigator ratings.

The study start date is 2017-06-19, and the primary completion date is 2017-07-07. Its status is TERMINATED. The reason for termination and whether termination affected data collection are not reported in the registry record. The stated primary outcome timeframe is 2 Months; the record does not explain the relationship between that timeframe and the listed completion date.

The record lists 2 outcome measures and 0 analyses. The secondary outcome is the number of investigator procedure surveys assessed by survey questionnaire. A primary outcome analysis, statistical analysis plan, and further detail about the conduct of data collection are not reported in the registry record. The primary outcome population excludes 1 subject who withdrew before study procedures using mobile fluoroscopy. The number of subjects contributing to each outcome is not otherwise described.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Excludes 1 (one) withdrawn subject because subject was withdrawn prior to study procedures using mobile fluoroscopy.

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 Imaging Guidance Adequacy Assessed by Number of Questionnaires, measured over 2 Months.

The primary endpoint is titled “Imaging Guidance Adequacy Assessed by Number of Questionnaires.” Its unit is an Image Guidance Adequacy Questionnaire, and the parameter is NUMBER. The description says it is a per-subject investigator report for procedure completion using the investigational device. The stated timeframe is 2 Months.

Questionnaire-based investigator reporting can be used to capture a clinician's assessment of how imaging guidance relates to completion of a procedure. In general, this kind of endpoint is descriptive: it records an assessment or report rather than directly comparing outcomes between randomized treatment groups. Its interpretation depends on how questions are phrased, how responses are categorized, and how the measure is summarized. Those details, including any threshold for adequacy and the number of questionnaires contributing to the endpoint, are not reported in the registry record.

The outcome title and unit refer to questionnaires, while the description refers to per-subject investigator reports. The record does not clarify whether each subject contributed one questionnaire, whether responses were combined across procedures, or how incomplete questionnaires were handled. It also does not post a primary endpoint value. As a result, the endpoint's intended subject matter is identifiable, but the recorded result and the scale on which it would be interpreted are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

In a single-group study, observations come from participants exposed to the same study intervention rather than from groups assigned to different interventions. This design can document what happened or what participants and investigators reported in the enrolled group. It cannot, on its own, separate the intervention's contribution from other factors that may influence the observation. Here, the registry lists the OEC Elite Imaging Arm and no comparator. The study's stated purpose—collecting survey data based on routine clinical use—fits a descriptive question, but does not create a controlled estimate of a treatment contrast.

What does a questionnaire endpoint represent?

A questionnaire endpoint turns responses to a set of questions into recorded data. In general, the meaning of those data depends on the items, response choices, scoring rules, and handling of unanswered items. A count of questionnaires is distinct from a score of adequacy: the former describes how many instruments were assessed, while a score or categorized response would describe what investigators reported. The registry's primary endpoint title refers to adequacy assessed by number of questionnaires, and its unit is an Image Guidance Adequacy Questionnaire. The description specifies a per-subject investigator report for procedure completion. The record does not state the instrument's questions, scoring rules, response categories, adequacy threshold, or observed value. Those omissions prevent a reader from determining how a response should be interpreted or summarized.

Why does the absence of a comparator matter?

A comparison estimates how outcomes differ between groups under specified conditions. Random allocation, when used, helps make groups comparable on average, while masking can reduce some influences on measurement or conduct. General statistical explanations do not substitute for design details: this registry records allocation as NA, masking as NONE, and the model as SINGLE GROUP. There is therefore no between-group estimate to interpret. Descriptive information from one group may still be useful for documenting experience, but it cannot establish what would have happened under a different device or approach.

What can an analysis add?

An analysis plan explains how collected observations will answer a study question: for example, which participants and records are included, how outcomes are summarized, and whether uncertainty or comparisons are assessed. The registry lists 0 analyses. It does not report an analysis plan, a primary outcome estimate, a confidence interval, or a test result. A confidence interval, in general, describes a range of values compatible with data under a specified statistical method; without a reported estimate and interval, precision cannot be assessed for the primary outcome. A p-value, when reported, quantifies compatibility with a null model under its assumptions; no such value is reported. Neither should be inferred from the study title, sample size, or adverse-event counts.

The stated primary outcome timeframe is 2 Months, but the record does not describe the timing of individual assessments or the length of observation for every participant. The primary completion date is 2017-07-07, while the study status is TERMINATED. The registry does not explain whether the outcome timeframe was fully observed or how termination related to planned follow-up. These registry entries matter because endpoint timing defines which observations enter an analysis and what period of experience the result represents.

How should planning illustrations be read?

Planning sample-size illustrations are hypothetical calculations, not observed trial findings. The stated assumptions describe two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with effects defined as fractions of the observed effect. For time-to-event illustrations, the stated quantity is the total number of events; other illustrations describe participants per arm. These assumptions do not match the registry's single-group design, which lists no allocation and no comparator. Such illustrations should not be read as the study's actual enrollment rationale, evidence that the study had a particular probability of detecting an effect, or a replacement for reported results. The registry does not report its own sample-size justification. Sample-size planning is also not observed power: it describes what a hypothetical design might require under assumptions, whereas observed power calculated from an observed result does not establish the reliability or importance of that result.

Finally, counts and estimates answer different questions. A count of participants at risk identifies the stated denominator for a safety category; a count of affected participants records events under the registry's definitions. Neither is an estimate of comparative risk in the absence of a comparator. For an adequacy questionnaire, a numerator without the precise assessed population, response definition, and uncertainty measure would likewise be difficult to interpret. Since those outcome details and analyses are not reported in the registry record, statistical methods can clarify what would be needed for interpretation, but cannot supply the missing endpoint result.

10. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study evaluates multiple outcomes, comparisons, time points, or subgroup analyses. In general, examining many results can increase the chance that at least one appears notable by chance, so an analysis plan may define a primary outcome and explain how other tests are handled. The registry lists 2 outcome measures: the primary questionnaire-based imaging-guidance adequacy outcome and a secondary outcome counting investigator procedure surveys assessed by survey questionnaire. It lists 0 analyses. Whether either outcome involved multiple response measures, time points, or subgroup analyses is not reported in the registry record. A multiplicity adjustment or strategy is also not reported in the registry record.

The record states that the primary outcome population excludes 1 subject who withdrew before study procedures using mobile fluoroscopy. This is a specific exclusion rule, but the registry does not explain how other missing information, incomplete questionnaires, or unavailable assessments were handled. The number contributing to each outcome is not reported in the registry record. The number enrolled should therefore not be assumed to equal the number analyzed for every measure.

Analysis populations are commonly defined in a protocol or analysis plan, with rules for inclusion and handling of deviations or missing data. The registry record does not report a protocol-defined analysis population, an intention-to-treat or per-protocol approach, imputation, or sensitivity analyses. Because the study is single-group, randomized-population terminology may not apply in the same way as it would in a randomized trial. The listed withdrawal exclusion gives limited information about one outcome's population but does not establish the full analysis set or the treatment of other missing observations.

No p-values or outcome estimates are reported, so the registry does not permit an assessment of multiplicity's practical effect on statistical conclusions. Missing-data assumptions and the impact of missing observations are also not reported in the registry record.

11. 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 safety record lists 12 at risk in the OEC Elite Imaging Arm. It records 0 affected for serious adverse events, 0 affected for other adverse events, and 0 deaths. No serious adverse-event terms are listed. These figures describe the entries in the registry; they do not show that the underlying risk is zero or that every possible event was captured.

Interpretation depends on how events were defined, collected, and followed over time. The registry record does not report the safety observation window, detailed event definitions, or additional event descriptions. It also has no comparator group, so these counts cannot be contrasted with event counts under another device or approach. The primary outcome's 2 Months timeframe should not be assumed to define safety follow-up, because that relationship is not reported.

In general, a count of 0 affected participants is an observation in the enrolled group, not proof that an event cannot occur. With enrollment of 12, the record offers a limited descriptive account and no comparative safety estimate. These data should be read as the posted counts, rather than as evidence of a risk-free device or a conclusion about safety relative to alternatives.

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

The registry record documents a clinical evaluation of the OEC Elite Mobile Fluoroscopy System in routine use, with survey-based assessment of imaging-guidance adequacy as the primary outcome. It identifies the study population as people undergoing vascular, gastrointestinal (GI), urology or pain management procedures for which the system was used. It also gives enrollment, an outcome timeframe, a specific withdrawal exclusion for the primary outcome population, and safety counts.

What the record does not establish is equally important. It does not report a primary endpoint result, a secondary survey-count result, or any analysis. Readers therefore cannot determine the observed adequacy responses, the number of questionnaires assessed, the precision of an estimate, or whether the results met any defined criterion. The questionnaire's scoring method and adequacy threshold are also not reported in the registry record.

The single-group design does not provide a comparison with another device or approach. Thus, even if descriptive questionnaire results were available, they would not by themselves estimate a relative difference or establish that the device caused a particular outcome. The registry does not report a randomized comparison, and masking is listed as NONE.

TERMINATED is the study status, but the reason and implications for outcome collection are not reported in the registry record. The record also does not report its own sample-size justification or detailed missing-data and analysis procedures. Planning illustrations based on hypothetical two-arm assumptions should not be mistaken for the study's actual design or for observed evidence.

The posted safety entries are 0 serious adverse events, 0 other adverse events, and 0 deaths among 12 at risk. Those counts are descriptive and do not demonstrate absence of risk. Overall, the record identifies what the study set out to collect and gives limited enrollment and safety information, but it does not provide the outcome results needed to judge the measured adequacy responses or their precision.

13. Why This Trial Matters Statistically

This study is statistically notable because its stated aim is descriptive, yet the registry record does not include the descriptive primary result. In device evaluations based on routine use, a clear account of the assessed population, the questionnaire instrument, the response definition, and the observed results is essential for readers to understand what the data represent. The record identifies an investigator-reported endpoint but does not report its value or scoring rules.

The design also illustrates why a study question must be matched to its structure. A single-group evaluation can document experience in people who used the device. It cannot estimate a comparative effect without a control group or otherwise defined comparator. The record's lack of allocation and its single-group model make it important to avoid interpreting the study as a randomized test of one option against another.

For biostatisticians and clinical researchers, the distinction between enrollment and analysis population is also relevant. Although enrollment is 12, the primary endpoint excludes 1 subject who withdrew before study procedures using mobile fluoroscopy, and the number contributing to the endpoint is not reported. That difference highlights why outcome-specific denominators and missing-data handling should be transparent.

Finally, planning assumptions are not the same as a study's actual design justification, and a hypothetical power calculation is not an observed result. The stated illustrations assume equal allocation between two arms, whereas this record describes one arm. Reading those concepts separately helps prevent a planning exercise from being mistaken for evidence about this study's precision or ability to detect a difference.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The principal limitation is the absence of posted primary and secondary outcome results. Although the registry identifies questionnaire-based imaging-guidance adequacy and the number of investigator procedure surveys assessed, it does not report the observed values, estimates of uncertainty, or analyses. The questionnaire's response scale, scoring rules, and threshold for adequacy are not reported in the registry record, limiting interpretation of the intended measure.

The study is single-group, with no comparator identified. Its design therefore cannot provide a controlled estimate of a difference between the OEC Elite system and another device or approach. Masking is listed as NONE. The registry does not describe additional safeguards for limiting observer or measurement influences.

Enrollment was 12, while the primary outcome population excludes 1 subject who withdrew before study procedures using mobile fluoroscopy. The record does not state the number contributing to each endpoint or how incomplete questionnaires and other missing data were handled. It also does not report a statistical analysis plan, outcome-specific analysis populations, or sensitivity analyses.

The study status is TERMINATED, but the reason for termination and its effect on data collection are not reported in the registry record. The record does not explain how the 2 Months primary outcome timeframe relates to the listed completion date or specify safety follow-up duration. Its own sample-size justification is not reported. These omissions constrain assessment of completeness, precision, and generalizability beyond the enrolled group.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System — NCT03096483.
• Registry record last updated 2019-03-27; status last verified 2019-03.
• Results first posted 2019-03-27.
• 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.

18. Record Summary

The registry record describes NCT03096483, a terminated, single-group clinical evaluation of the OEC Elite Mobile Fluoroscopy System sponsored by GE Healthcare. Enrollment was 12, and the listed arm involved vascular, gastrointestinal (GI), urology or pain management procedures using the device. Allocation is NA, masking is NONE, and phase is NA.

The primary outcome concerns imaging-guidance adequacy assessed by questionnaire, with a stated timeframe of 2 Months. Its population excludes 1 subject who withdrew before study procedures using mobile fluoroscopy. The secondary outcome is the number of investigator procedure surveys assessed by survey questionnaire. The record lists 2 outcome measures and 0 analyses, but reports no outcome results.

The listed safety counts are 0 serious adverse events, 0 other adverse events, and 0 deaths among 12 at risk. The study start date is 2017-06-19, and the primary completion date is 2017-07-07. The reason for termination, detailed analysis methods, and outcome findings are not reported in the registry record.