This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Double-J PLUS Postmarket Registry Study (NCT04197583), a registered phase not stated study. The primary outcome is Percentage of Implanted Stents Meeting the Technical Success Criteria.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04197583 |
| Phase | Phase not stated |
| Condition | Ureter Obstruction |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 379 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boston Scientific Corporation |
| Results posted | Yes |
2. Clinical Question
Population
People with ureter obstruction who consented and for whom placement of a Boston Scientific stent procedure was initiated. The record reports enrollment of 379. The primary endpoint population is described as subjects meeting those criteria, while the units analyzed were stents implanted for more than 12 hours.
Intervention
Boston Scientific ureteral stents and urinary diversion stents. The registry record reports separate summaries for Tria and Non-Tria stents.
Comparator
No randomized comparator is described. Tria and Non-Tria are separate device groups, not a like-for-like control comparison; allocation is not stated.
Primary question
What percentage of implanted stents met the registry’s technical-success criteria during the stated timeframe of 2 months to 15 Months? Success required drainage from a stented kidney to the bladder during planned indwell time, without re-intervention due to obstruction of the stented ureters. The registry record does not report the numerical primary-endpoint result.
This is a postmarket registry question about device performance and safety in clinical use, rather than a randomized test of one treatment against another. The brief summary describes a multi-center global registry intended to obtain post-market safety and efficacy data on Boston Scientific ureteral and urinary diversion stents. Its primary outcome focuses on whether the stented kidney drains as intended over the planned indwell period without a specific obstruction-related re-intervention.
The registry enrolled 379 participants, but the unit for the primary endpoint is a stent, not necessarily a participant. The record says that stents implanted for more than 12 hours were analyzed and that results were summarized separately for Tria and Non-Tria. It also identifies an 85% performance goal for Tria stone management. The posted results do not give the technical-success counts or percentages needed to judge that endpoint against the goal, nor do they explain how the performance goal was used in analysis.
3. Trial Design
The registry is titled Double-J PLUS Postmarket Registry Study, with the official title Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry. Boston Scientific Corporation is listed as sponsor. The study is marked completed, with a start date of 2020-02-19 and a primary completion date of 2023-01-16. The registry describes a multi-center global study of Boston Scientific ureteral and urinary diversion stents for people with ureter obstruction.
The intervention is a device: Boston Scientific ureteral stents and urinary diversion stents. The primary outcome is the percentage of implanted stents meeting technical-success criteria. The outcome timeframe is 2 months to 15 Months. The definition requires that a stented kidney drain to the bladder during planned indwell time, without re-intervention due to obstruction of the stented ureters.
The primary population description includes subjects who consented and for whom a Boston Scientific stent placement procedure was initiated. The unit of analysis is narrower: stents implanted for more than 12 hours. Results were intended to be summarized separately for Tria and Non-Tria. Enrollment is 379, but the record does not give the number of stents analyzed for the primary endpoint or how participants with multiple stents were handled.
This registry is not described as a randomized comparison. Allocation is not stated, and the Tria and Non-Tria groups are not a like-for-like control comparison. The record lists quality-of-life patient-reported outcomes and stent migration as secondary outcomes, and four outcome measures in total. It reports one analysis. The protocol details, recruitment procedures, follow-up schedule beyond the primary endpoint timeframe, and any additional design features 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.
Before assignment: This section is not applicable.
Overall Study
| Stage | Boston Scientific Tria Ureteral Stents | Boston Scientific Non- Tria Ureteral Stents |
|---|---|---|
| STARTED | 215 | 164 |
| COMPLETED | 162 | 131 |
| NOT COMPLETED | 53 | 33 |
Reasons for not completing this period:
| Reason | Boston Scientific Tria Ureteral Stents | Boston Scientific Non- Tria Ureteral Stents |
|---|---|---|
| Study Stent Replacement | 34 | 8 |
| Lost to Follow-up | 14 | 3 |
| Death | 3 | 0 |
| Physician Decision | 1 | 0 |
| Withdrawal by Subject | 1 | 1 |
| Discontinued. Patient had disseminated metastatic condition | 0 | 1 |
| Screen Failure | 0 | 20 |
Analysis population for the primary outcome, as defined in the registry: Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included. Number of units analyzed are stents implanted for more than 12 hours. Results were summarized by Tria and Non-Tria separately. Performance goal was 85% for Tria stone management.
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: 20 Non-Tria subjects were screen failures and did not complete the Index Procedure.
| Characteristic | Unit | Boston Scientific Ureteral Stents - Tria | Boston Scientific Ureteral Stents - Non-Tria | Total |
|---|---|---|---|---|
| Participants analysed | 215 | 144 | 359 | |
| Age, Continuous | years | 57.2 (19 to 90) | 60.0 (23 to 85) | 58.4 (19 to 90) |
| Sex: Female, Male: Female | Participants | 99 | 58 | 157 |
| Sex: Female, Male: Male | Participants | 116 | 86 | 202 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: Canada | participants | 29 | 18 | 47 |
| Region of Enrollment: United States | participants | 166 | 98 | 264 |
| Region of Enrollment: Japan | participants | 20 | 0 | 20 |
| Region of Enrollment: France | participants | 0 | 28 | 28 |
| Quality of Life Endpoint - Patient-Reported Outcomes: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a | units on a scale | 44.34 (30.7 to 71.8) | 43.15 (30.7 to 71.8) | 43.86 (30.7 to 71.8) |
| Quality of Life Endpoint - Patient-Reported Outcomes: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 6b | units on a scale | 55.09 (41.0 to 78.2) | 53.85 (41.0 to 78.2) | 54.59 (41.0 to 78.2) |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Implanted Stents Meeting the Technical Success Criteria, measured over 2 months to 15 Months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Units |
| Measure of spread | not applicable |
| Unit | Stent Implanted |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the percentage of implanted stents meeting a technical-success definition. Success is defined as drainage from the stented kidney to the bladder during the planned indwell time, with no re-intervention due to obstruction of the stented ureters. The outcome timeframe is 2 months to 15 Months. Stents implanted for more than 12 hours were the units analyzed, and the registry says results were summarized separately for Tria and Non-Tria.
This type of endpoint is used to describe whether a device achieved a specified functional objective during the period it was intended to remain in place. It combines a drainage requirement with the absence of a particular intervention prompted by obstruction. As a general statistical point, a clearly defined endpoint helps readers understand what a reported success represents and which clinical events count against it. Here, the endpoint is about stents, whereas enrollment is reported in participants; those units should not be treated as interchangeable.
The registry record does not report the number of stents meeting the definition, the percentage meeting it, or an uncertainty interval around that percentage. It therefore does not permit a numerical assessment of the primary endpoint from the posted results described in the record. The record identifies an 85% performance goal for Tria stone management, but does not report the endpoint result needed to interpret that goal or explain the statistical procedure used with it.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record characterizes a completed postmarket study of Boston Scientific ureteral and urinary diversion stents. It reports enrollment of 379 and describes technical success as the primary endpoint, with success based on drainage during planned indwell time without re-intervention due to obstruction. The outcome timeframe is 2 months to 15 Months. However, the posted results do not report a numerical primary-endpoint result. No success count, percentage, or confidence interval is available in the record, so the primary endpoint cannot be quantified from these results.
The record says the primary endpoint was summarized separately for Tria and Non-Tria, and identifies an 85% performance goal for Tria stone management. It does not report the Tria or Non-Tria technical-success results, nor a statistical comparison with the performance goal. The goal alone is not evidence that the endpoint was or was not met. Without the observed endpoint values and their precision, no conclusion about performance relative to that goal can be drawn from the registry record.
Safety information is reported by device group. For Boston Scientific Ureteral Stents - Tria, 215 were at risk for serious adverse events, 9 were affected, 215 were at risk for other adverse events, 57 were affected, and deaths were 3. For Boston Scientific Ureteral Stents - Non-Tria, the corresponding figures are 144, 5, 144, 40, and 0. These figures describe the record’s reported safety counts. They do not establish that observed differences between groups were caused by device type. The registry is not a randomized comparison, allocation is not stated, and the groups are not a like-for-like control comparison.
The registry also lists serious-event terms with percentages: Sepsis, 1.4%; Urinary Tract Infections, 1.4%; Urinary Retention, 0.9%; Myocardial Infarction, 0.7%; Renal Pain, 0.7%; and Pyelonephritis, 0.7%. The record does not describe the denominator or the method used to produce these percentages. They should therefore be read as listed safety summaries, not as a basis for additional calculations or comparisons.
In general, statistical precision is important because an estimate based on a finite group can vary from the value that would be observed in a broader population. A confidence interval, if reported, would describe uncertainty around an estimate under its statistical assumptions. No such interval for technical success is reported in the registry record. Safety counts likewise do not on their own show how precise a group difference may be, and no randomized comparative effect estimate is reported.
9. Statistical Methods Explained
The registry record presents a count-based primary outcome: the percentage of implanted stents meeting a defined technical-success criterion. It identifies stents implanted for more than 12 hours as the units analyzed and states that results were summarized separately for Tria and Non-Tria. The posted results described in the record do not include the success counts or percentages. Accordingly, no estimate of technical success or uncertainty around it can be interpreted from the registry record.
What does a count-based endpoint represent?
In general, a count-based endpoint records how many units satisfy a definition or experience an event. When the intended summary is a percentage, the count must be interpreted in relation to the relevant denominator. The choice of unit matters: this endpoint uses implanted stents, while enrollment is reported as participants. If a participant can contribute more than one stent, observations from the same participant may be related rather than independent. The record does not report how many stents each participant contributed or how any within-participant dependence was handled.
The endpoint definition combines two conditions: drainage to the bladder during planned indwell time and no re-intervention due to obstruction of the stented ureters. In general, a composite definition can be useful when several requirements together describe the intended outcome. It also means that a unit does not qualify as a success if any required element is not satisfied. The registry record does not provide separate results for the drainage and re-intervention components, so their individual contributions cannot be assessed.
How should uncertainty be understood?
In general, an estimate describes the observed study data, while an uncertainty interval describes the range of values reasonably compatible with those data under a specified statistical model. A narrower interval indicates greater precision under that model; a wider interval indicates less precision. An interval does not remove limitations in the study design or guarantee that the underlying assumptions are correct. The registry record does not report a confidence interval for the primary endpoint, and the numerical endpoint estimate itself is not reported. Thus, neither the observed magnitude nor its statistical precision can be evaluated.
A performance goal can serve as a benchmark, but its interpretation depends on the prespecified analysis and the observed estimate and uncertainty. The registry record identifies an 85% performance goal for Tria stone management. It does not report whether the goal was prespecified as a formal hypothesis, what inferential procedure was used, or how the observed result related to the goal. Without those details and the endpoint result, the goal should not be treated as a finding.
What can be inferred from the safety summaries?
The safety information gives counts for participants at risk and affected by serious and other adverse events, alongside deaths, separately for Tria and Non-Tria. In general, a count is descriptive. Interpreting it as a risk requires clarity about the denominator, event definition, observation period, and whether repeated events or people are counted. The record supplies at-risk and affected counts for the listed safety groups, but does not give further details about event ascertainment, follow-up completeness, or whether an affected count represents people with at least one event or event occurrences.
Group comparisons require particular caution. General statistical reasoning distinguishes an observed difference from a causal effect. In a randomized comparison, assignment procedures can support balanced groups on average, subject to study conduct and chance. This registry is not described as randomized, allocation is not stated, and the groups are not a like-for-like control comparison. Therefore, the reported group-specific counts do not establish that device type caused any difference. No adjusted comparative estimate or uncertainty interval is reported.
What does the planning illustration mean?
General sample-size planning asks how many observations may be needed to detect an effect under stated assumptions. The planning illustration associated with the registry is described as being based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers an effect that is a stated fraction of the observed effect. These are planning assumptions, not evidence about the study’s actual design or conduct. The record does not report that these assumptions were used to plan the registry, and the illustration is not observed power.
The record also specifies that planning values for non-time-to-event outcomes are participants per arm, while time-to-event values would represent the total number of events. The primary endpoint is described in terms of stents, and the registry record does not report a numerical primary result for it. Any planning illustration should therefore be kept separate from observed outcomes, and should not be read as an estimate of the registry’s achieved statistical power. The study’s own sample-size justification is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists four outcome measures and one analysis. It identifies the primary endpoint as the percentage of implanted stents meeting technical-success criteria and lists quality-of-life patient-reported outcomes and stent migration among the secondary outcomes. It does not report a multiplicity strategy, such as whether statistical testing was adjusted across outcomes or whether any outcomes were designated as exploratory. The registry record also does not state whether additional analyses were planned but not reported.
In general, multiplicity arises when many outcomes or comparisons are examined. If each is tested separately, the chance of at least one apparently notable result can increase. An analysis plan may address this by prioritizing outcomes or adjusting inference. Without a reported multiplicity plan, the interpretation of any collection of statistical tests would be uncertain. In this record, the primary endpoint result itself is not numerically reported, and no inferential results for secondary outcomes are described.
Missing-data procedures are not reported in the registry record. The record does not describe follow-up completeness, how missing outcome measurements were handled, or whether any participants or stents were excluded from particular analyses beyond the stated criterion that analyzed stents were implanted for more than 12 hours. It also does not report how outcomes unavailable at the planned assessment were treated.
Analysis populations are described only in part. The primary population includes subjects who consented and for whom a stent placement procedure was initiated, while the units analyzed were stents implanted for more than 12 hours. The record does not report a full accounting from enrollment to endpoint analysis, the number of stents analyzed by group, or whether all eligible units were included. Consequently, the relationship between enrollment, the endpoint population, and the analyzed stent counts cannot be reconstructed from the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Boston Scientific Ureteral Stents - Tria | 9 | 215 | 4.2% |
| Boston Scientific Ureteral Stents - Non-Tria | 5 | 144 | 3.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Boston Scientific Ureteral Stents - Tria | 3 of 215 |
| Boston Scientific Ureteral Stents - Non-Tria | 0 of 144 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Boston Scientific Ureteral Stents - Tria | 57 of 215 |
| Boston Scientific Ureteral Stents - Non-Tria | 40 of 144 |
Most frequent serious adverse event terms
| Event term | Organ system | Boston Scientific Ureteral Stents - Tria | Boston Scientific Ureteral Stents - Non-Tria |
|---|---|---|---|
| Sepsis | Infections and infestations | 3 of 215 | 0 of 144 |
| Urinary Tract Infections | Infections and infestations | 0 of 215 | 2 of 144 |
| Urinary Retention | Renal and urinary disorders | 2 of 215 | 0 of 144 |
| Pneumonia | Infections and infestations | 1 of 215 | 0 of 144 |
| Pyelonephritis Acute | Infections and infestations | 1 of 215 | 0 of 144 |
| Myocardial Infarction | Cardiac disorders | 0 of 215 | 1 of 144 |
| Urinary Bladder Haemorrhage | Renal and urinary disorders | 1 of 215 | 0 of 144 |
| Atrial Fibrillation | Cardiac disorders | 1 of 215 | 0 of 144 |
| Cardiac Valve Disease | Cardiac disorders | 1 of 215 | 0 of 144 |
| Prostate Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 215 | 0 of 144 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Boston Scientific Ureteral Stents - Tria | Boston Scientific Ureteral Stents - Non-Tria |
|---|---|---|---|
| Flank Pain | Musculoskeletal and connective tissue disorders | 9 of 215 | 16 of 144 |
| Procedural Pain | Injury, poisoning and procedural complications | 9 of 215 | 13 of 144 |
| Pain | General disorders | 15 of 215 | 1 of 144 |
| Urethral Pain | Renal and urinary disorders | 6 of 215 | 0 of 144 |
| Dysuria | Renal and urinary disorders | 2 of 215 | 3 of 144 |
| Haematuria | Renal and urinary disorders | 1 of 215 | 4 of 144 |
| Renal Colic | Renal and urinary disorders | 2 of 215 | 1 of 144 |
| Urinary Tract Infection | Infections and infestations | 3 of 215 | 0 of 144 |
| Abdominal Pain | Gastrointestinal disorders | 1 of 215 | 1 of 144 |
| Back Pain | Musculoskeletal and connective tissue disorders | 0 of 215 | 2 of 144 |
Serious events with the highest arm-level rate: sepsis (1.4%), urinary tract infections (1.4%), urinary retention (0.9%), myocardial infarction (0.7%), renal pain (0.7%).
For Boston Scientific Ureteral Stents - Tria, the registry reports 215 at risk for serious adverse events and 9 affected; it reports 215 at risk for other adverse events and 57 affected, with 3 deaths. For Boston Scientific Ureteral Stents - Non-Tria, the corresponding values are 144 at risk for serious adverse events and 5 affected; 144 at risk for other adverse events and 40 affected, with 0 deaths. These are the safety counts as reported for the two groups.
The registry also lists the following serious adverse-event terms and percentages: Sepsis, 1.4%; Urinary Tract Infections, 1.4%; Urinary Retention, 0.9%; Myocardial Infarction, 0.7%; Renal Pain, 0.7%; and Pyelonephritis, 0.7%. The record does not report the denominator or explain whether the percentages refer to participants, events, or another basis. They should be read as registry-listed summaries rather than recalculated or directly compared with the group counts.
In general, safety counts describe what was reported during observation, but interpretation also depends on event definitions, follow-up, and how repeated events were counted. The record does not provide further detail on those points. Because this was not a randomized comparison, allocation is not stated, and the groups are not a like-for-like control comparison, the counts do not show that one device group caused more or fewer events than the other.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed postmarket registry was conducted to obtain safety and efficacy data on Boston Scientific ureteral and urinary diversion stents. It describes a primary technical-success endpoint and gives a definition tied to kidney drainage and obstruction-related re-intervention. It also reports safety counts by Tria and Non-Tria group and lists several serious adverse-event terms with percentages. These are descriptive features of the record.
The primary endpoint result is not reported numerically. The record therefore does not establish the observed percentage of stents that met the technical-success definition, how that percentage differed between Tria and Non-Tria, or how it related to the 85% performance goal identified for Tria stone management. It also does not report a confidence interval or other measure of precision for technical success. The absence of a reported result is not evidence of either success or failure.
The safety counts can be read as the numbers reported for the stated groups, but not as a randomized comparison. The registry is not described as randomized, allocation is not stated, and the groups are not a like-for-like control comparison. Differences in observed counts cannot be attributed to device type on the basis of these registry entries alone. The record does not report an adjusted comparative analysis that would address differences between the groups.
In general, registry evidence can describe outcomes under observed clinical use, while the strength of causal conclusions depends on design and analysis. Descriptive findings may help characterize what was recorded, but do not by themselves isolate the effect of a device from other influences. Interpretation also depends on the completeness of follow-up, outcome ascertainment, and the handling of missing observations; these details are not reported in the registry record.
The findings should therefore be understood within the information the record reports: a completed postmarket registry, a defined endpoint, separate safety summaries, and no numerical primary-endpoint result. The record does not support a numerical conclusion about primary technical success or a causal comparison between device groups.
13. Why This Trial Matters Statistically
Postmarket registries address questions about device use and outcomes beyond a controlled experimental setting. This registry is described as multi-center and global, and its stated aim is to obtain post-market safety and efficacy data on Boston Scientific ureteral and urinary diversion stents. Such a setting can make it important to define what counts as a successful device outcome and to report how safety events are summarized.
Statistically, the primary endpoint highlights the distinction between participants and outcome units. Enrollment is reported as 379 participants, while the primary endpoint is expressed as a percentage of implanted stents and includes stents implanted for more than 12 hours in the analyzed units. These denominators answer different questions. Clear reporting of the number of analyzed stents and their relationship to participants is important for understanding the precision and interpretation of a stent-level estimate.
The record also illustrates why design context matters when reading group summaries. Tria and Non-Tria results are described separately, but the registry is not a randomized comparison, allocation is not stated, and the groups are not a like-for-like control comparison. A difference between descriptive counts would not, by itself, show that the device group caused the difference.
Finally, a precisely defined endpoint is not enough to judge the result if the numerical estimate is unavailable. The registry specifies technical success and identifies an 85% performance goal for Tria stone management, but does not report the technical-success result or its uncertainty. This limits statistical interpretation: the endpoint’s meaning is clear, while its observed performance cannot be evaluated from the registry record. The distinction between a stated outcome, a reported estimate, and an inferential conclusion is central to responsible reading of registry evidence.
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 for interpreting the primary outcome is that the registry record does not report a numerical technical-success result. Although the endpoint definition, timeframe, analyzed-unit criterion, and Tria stone-management performance goal are described, the success counts and percentages are not reported. The record also does not give an uncertainty interval or explain how the performance goal was used in an analysis.
The unit distinction limits reconstruction of the analysis population. Enrollment is reported as 379 participants, whereas the primary endpoint is based on stents implanted for more than 12 hours. The number of analyzed stents by group and the handling of participants with multiple stents are not reported in the registry record. The record does not provide a full accounting of how many enrolled participants or initiated procedures contributed to each outcome.
The registry is not a randomized comparison, allocation is not stated, and Tria and Non-Tria are not like-for-like control groups. The group-specific safety counts should therefore not be interpreted as causal contrasts. The record does not report an adjusted comparative analysis or uncertainty estimates for between-group differences.
Other relevant details are also not reported in the registry record: missing-data procedures, follow-up completeness, event ascertainment procedures, the treatment of repeated events, the full statistical analysis plan, and a multiplicity strategy. The record lists four outcome measures and one analysis but does not explain how outcomes were prioritized beyond identifying the primary endpoint. These omissions restrict assessment of selection, precision, and robustness. They do not establish that a particular bias occurred; they mean that the record does not provide enough information to evaluate these issues fully.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Double-J PLUS Postmarket Registry Study — NCT04197583.
- Registry record last updated 2026-03-03; status last verified 2026-02.
- Results first posted 2024-10-16.
- 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.
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18. Record Summary
Double-J PLUS Postmarket Registry Study is a completed postmarket registry sponsored by Boston Scientific Corporation. The record reports enrollment of 379, a start date of 2020-02-19, and a primary completion date of 2023-01-16. It concerns Boston Scientific ureteral and urinary diversion stents for ureter obstruction.
The primary endpoint is the percentage of implanted stents meeting a technical-success definition during 2 months to 15 Months. Success requires drainage to the bladder during planned indwell time without re-intervention due to obstruction of the stented ureters. Stents implanted for more than 12 hours were the analyzed units, with Tria and Non-Tria results intended to be summarized separately. The registry record does not report the numerical primary-endpoint result.
Safety counts are reported for both device groups, alongside a list of serious adverse-event terms and percentages. The registry is not a randomized comparison, allocation is not stated, and the groups are not like-for-like controls. Missing-data procedures, multiplicity handling, and further statistical-plan details are not reported in the registry record.