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 Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD (NCT04087213), a na na study. The primary outcome is Primary Safety Endpoint.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04087213 |
| Phase | NA |
| Condition | End-Stage Renal Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 36 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Deka Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
People with end-stage renal disease who used the HemoCare™ Hemodialysis System at least once during the Assisted Evaluable Period. The record defines this as the intention-to-treat population for the primary endpoint. Enrollment was 36.
Intervention
Use of the HemoCare™ Hemodialysis System for nocturnal hemodialysis at home, considered across assisted and unassisted home evaluable periods. The record describes the study as prospective, multicenter, and open-label.
Comparator
There is no separate randomized control group. The record describes a single-group study, with observations during an Assisted Evaluable Period and an Unassisted Home Evaluable Period. These periods are not a like-for-like randomized comparison.
Primary question
What adverse-event rate per 100 HemoCare™ Hemodialysis System treatments was observed during the assisted and unassisted home evaluable periods? The primary endpoint is identified, but its numerical result is not reported in the registry record.
The study’s stated purpose was to gather and evaluate safety data for nocturnal use of the device. The registry record identifies people with end-stage renal disease as the relevant clinical population and defines the primary-endpoint population by device use during the assisted period. That definition is important: it is a use-based population, not a comparison of independently assigned treatment groups.
The research question is therefore descriptive and safety-focused. It concerns adverse events in relation to treatment exposure across two stages of home use. The record does not describe a randomized comparison with another device, a usual-care group, or a no-treatment group. Nor does it establish that the two evaluable periods represent exchangeable groups. The periods may help describe safety as use changes from assisted to unassisted home treatment, but they do not by themselves isolate the effect of assistance or demonstrate a causal difference between the periods.
The registry record lists other safety and clinical measures, including adverse events and serious adverse events, changes in post-dialysis serum phosphorus and potassium, and weight and fluid-removal comparisons between evaluable periods. These listed outcomes indicate the range of information the study intended to collect; they do not supply numerical results for those outcomes. The primary adverse-event rate result, treatment exposure used in its calculation, and any uncertainty interval are not reported in the registry record.
3. Trial Design
The registry record describes a prospective, multicenter, open-label, single-arm study of the HemoCare™ Hemodialysis System for home nocturnal hemodialysis in people with end-stage renal disease. Enrollment was 36. The study began on 2019-09-05, had a primary completion date of 2023-01-11, and is marked completed. The phase and allocation are recorded as NA, and masking is listed as none.
Because the study is single-group and has no randomized allocation, it is not designed as a controlled comparison between independently assigned groups. The record distinguishes an Assisted Evaluable Period from an Unassisted Home Evaluable Period. Their labels describe periods of evaluation, but do not establish that participants were randomized to them or that the periods are comparable in all other respects. Any difference between observations across periods could reflect changes in exposure, participant circumstances, or other factors; the registry record does not report an analysis that separates these possibilities.
The primary endpoint is an adverse-event rate per 100 HemoCare™ Hemodialysis System treatments during the assisted and unassisted home evaluable periods. Its stated timeframe is 31 weeks. A rate is intended to relate events to exposure, rather than simply report an event count. However, the registry record does not report the number of treatments used in the denominator, the observed rate for either period, or an estimate comparing the periods.
The study’s stated purpose is safety evaluation, and the record lists additional outcomes concerning adverse events, serum phosphorus and potassium, weight, and fluid removed. The record does not report a statistical analysis plan, a sample-size justification, interim analyses, or a detailed account of how missing measurements were handled. No statistical analyses are listed in the registry results record. The absence of those details limits assessment of how the planned outcomes were analyzed and how precise their estimates are.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: A required introduction to the HemoCare hemodialysis system and successful training for cannulation/ vascular access care at the study site for a minimum of 1-week prior to first home treatment (In-Facility Introduction Period).
In-Facility Introduction
| Stage | Assisted Home Hemodialysis Then Unassisted Home Hemodialysis |
|---|---|
| STARTED | 36 |
| COMPLETED | 34 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Assisted Home Hemodialysis Then Unassisted Home Hemodialysis |
|---|---|
| Withdrawal by Subject | 1 |
| Adverse Event | 1 |
Transition Period A
| Stage | Assisted Home Hemodialysis Then Unassisted Home Hemodialysis |
|---|---|
| STARTED | 34 |
| COMPLETED | 34 |
| NOT COMPLETED | 0 |
Assisted Evaluable Period
| Stage | Assisted Home Hemodialysis Then Unassisted Home Hemodialysis |
|---|---|
| STARTED | 34 |
| COMPLETED | 29 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | Assisted Home Hemodialysis Then Unassisted Home Hemodialysis |
|---|---|
| Withdrawal by Subject | 2 |
| Personal reasons | 3 |
Transition Period B
| Stage | Assisted Home Hemodialysis Then Unassisted Home Hemodialysis |
|---|---|
| STARTED | 29 |
| COMPLETED | 28 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Assisted Home Hemodialysis Then Unassisted Home Hemodialysis |
|---|---|
| Renal Transplantation | 1 |
Analysis population for the primary outcome, as defined in the registry: The ITT population was defined as all subjects who used HemoCare Hemodialysis System at least once during the Assisted Evaluable Period.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Intent-To-Treat (ITT) Population |
|---|---|---|
| Participants analysed | 34 | |
| Age, Continuous | years | 48.0 (SD 11.2) |
| Sex: Female, Male: Female | Participants | 12 |
| Sex: Female, Male: Male | Participants | 22 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 24 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 10 |
| Race (NIH/OMB): White | Participants | 23 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 34 |
6. Primary Endpoint
The registry lists the primary outcome as Primary Safety Endpoint, measured over 31 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Adverse Events per 100 Treatments |
| Endpoint classification | Event-Rate Endpoint |
The primary endpoint is the adverse-event rate per 100 HemoCare™ Hemodialysis System treatments during the Assisted and Unassisted Home Evaluable Periods. Its stated timeframe is 31 weeks. Unlike a simple event count, an event rate relates the number of events to the amount of treatment exposure. This can be useful when participants contribute different amounts of exposure, since a count alone does not show how much treatment time or how many treatments were observed.
To interpret a rate, readers need both the event count and the exposure denominator, as well as the method used to define and count events. The registry record does not report the observed primary rate, the number of treatments contributing to each period, or a confidence interval for the rate. It therefore does not allow the magnitude or precision of the primary endpoint estimate to be assessed.
The endpoint is safety-focused: it describes adverse events associated in time with device treatments, not whether the device caused them. Attribution requires careful event definitions and assessment procedures; the registry record does not report those details. Nor does a rate by itself establish whether the observed frequency is meaningfully different from another treatment or from an expected background frequency. The record identifies the endpoint and its exposure-based unit, but does not provide the numerical result needed to interpret the observed rate.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies an exposure-based primary safety endpoint, but it does not report the primary adverse-event rate. It also does not report the underlying number of events or treatments, a confidence interval, or a statistical test for the endpoint. As a result, the posted registry information does not show the estimated event rate or how precisely it was measured. No claim about the size of the primary endpoint can be made from the record.
The study design matters to interpretation. This is a single-arm, open-label study, not a randomized comparison. Its assisted and unassisted home periods are evaluation periods within the study, not randomized control arms. Observations across these periods can describe what was recorded during each stage, but a difference between periods would not, by itself, show that the change in assistance caused a difference in adverse events. Other differences in exposure or circumstances could contribute, and the registry record does not report methods to address such factors.
The adverse-event summary does report serious-event figures for each period. For the Assisted Evaluable Period, it lists 5 affected among 34 at risk; for the Unassisted Home Evaluable Period, it lists 2 affected among 28 at risk. These figures should be read as registry summaries, not as a randomized comparison or an estimate of causal effect. The record does not report uncertainty intervals or a statistical comparison for these figures. It also lists serious-event terms with percentages, including vascular access site thrombosis and dyspnea at 3.6% each, and bacteremia, pneumonia, hypervolemia, and anxiety at 2.9% each. The registry record does not provide enough detail to determine the denominators or event-counting rules behind those percentages.
The primary population is defined as people who used the device at least once during the assisted evaluable period. That definition clarifies who is included in the intended primary analysis, but the registry record does not report how many participants contributed to the primary rate estimate or how missing information was handled. Enrollment alone cannot establish the analysis denominator or the amount of treatment exposure.
Overall, the record supports a description of study purpose, design, endpoint, and selected serious adverse-event summaries. It does not provide the primary result required to assess the reported treatment-related event rate or its precision. The record also does not support a conclusion about comparative safety, since there was no randomized control group and no reported between-period analysis.
9. Statistical Methods Explained
Statistical interpretation starts with identifying what the study measures, who contributes information, and what comparison the design permits. Here, the primary measure is an adverse-event rate per 100 treatments, and the record describes a prospective, open-label, single-arm study. The distinction between a rate and a count, and between an evaluation period and a randomized arm, is central to reading the registry information.
What does an exposure-based rate mean?
In general, a rate relates events to an amount of exposure. The exposure denominator might be treatment sessions, person-time, or another defined unit, depending on the study. This allows the frequency of events to be described in relation to how much observation or treatment occurred. The unit specified in this record is adverse events per 100 treatments.
Rates depend on consistent definitions of both events and exposure. Readers need to know whether repeat events in the same participant are counted separately, how events are attributed to a treatment period, and how treatments are counted. The registry record does not report those details or the treatment counts used for the primary endpoint. It also does not report the numerical primary rate. Without the numerator and denominator, readers cannot independently assess the rate or its precision.
Why is the study design important?
In general, random assignment can help make groups comparable with respect to factors that might otherwise affect outcomes. This study is listed as single-group, with allocation recorded as NA and masking as none. It distinguishes assisted and unassisted home evaluable periods, but the registry record does not describe them as randomized comparison groups. A comparison between period summaries would therefore be descriptive unless supported by additional design and analysis details. Even if the summaries differed, the difference could not automatically be attributed to the change in period or assistance.
Open-label means the study is not masked according to the registry record. In general, knowledge of treatment can influence reporting, observation, or assessment, depending on the outcome and study procedures. The record does not describe safeguards for event assessment, so their use cannot be assumed. This is particularly relevant when an endpoint includes adverse events whose identification or classification involves judgment.
What would a confidence interval add?
In general, a confidence interval expresses the uncertainty around an estimated quantity under the assumptions of the statistical method. It gives readers information about precision that a point estimate alone cannot convey. It does not guarantee that the true value lies within the interval, and it does not resolve bias or design limitations. For an event rate, the interval would help show how much statistical uncertainty remains around the estimated rate.
The registry record does not report a confidence interval for the primary endpoint or for the serious adverse-event figures. It also does not report the primary estimate itself. Thus, the precision of the main safety measure cannot be evaluated from the registry record. The record contains no listed statistical analyses, so a model, test, or interval method cannot be identified.
How should repeated events be considered?
In general, an event rate may count multiple events for the same participant. If events cluster within participants, treating every event as if it came from an unrelated person can understate uncertainty. Some methods account for this dependence or for variation in event rates across participants. Whether that issue applies, and how it was handled, depends on the endpoint definition and analysis. The registry record does not report whether repeated events were included, how within-participant dependence was handled, or whether over-dispersion was assessed.
The adverse-event figures listing participants at risk and affected are not interchangeable with the primary rate per 100 treatments. The former are summaries based on the categories recorded in the safety results; the latter requires treatment exposure as its denominator. They answer different descriptive questions and should not be substituted for one another.
What can the planning illustrations say?
In general, a sample-size calculation can illustrate the amount of information that might be needed under chosen assumptions. The planning description associated with this analysis says it uses the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect set as a stated fraction of the observed effect. For time-to-event calculations it describes total events; other calculations are described as participants per arm.
These are planning illustrations, not observed power and not evidence that the original study was designed around those assumptions. They do not change the single-arm design of this study, and they do not supply a missing primary result. The registry record does not report the study’s own sample-size justification or statistical plan. Since the primary effect estimate is not reported, the planning assumptions cannot be interpreted as a substitute for the observed safety findings.
In general, sound interpretation also depends on complete outcome definitions, analysis populations, exposure accounting, missing-data procedures, and prespecified methods. Those details help readers distinguish planned analyses from exploratory ones and understand what population an estimate represents. Several of these details are not reported in the registry record. The design and endpoint can be described, but the principal analysis cannot be reconstructed from the record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary safety endpoint and several secondary outcomes, including total adverse events and serious adverse events, changes in post-dialysis serum phosphorus and potassium, and comparisons of weight change and fluid removed between evaluable periods. When a study assesses multiple outcomes, the chance of at least one apparently notable result can increase if each is tested separately. In general, a prespecified multiplicity strategy can clarify whether and how statistical evidence is adjusted across outcomes. The registry record does not report such a strategy, a hierarchy among secondary outcomes, or results of statistical tests. No analyses are listed in the registry results record.
Missing-data handling is also important because participants may have incomplete measurements or different amounts of treatment exposure. In general, an analysis should explain how missing observations affect the population and estimates, and whether any assumptions or sensitivity analyses were used. The registry record does not report how missing data were handled, whether all enrolled participants contributed to each outcome, or how incomplete periods were treated. Enrollment of 36 does not establish the denominator for any specific endpoint.
The record defines the primary intention-to-treat population as all subjects who used the HemoCare Hemodialysis System at least once during the Assisted Evaluable Period. This definition identifies the intended population, but it does not state how many people were included in the actual primary analysis or whether the population definition was applied exactly as planned. Per-outcome analysis populations are not reported in the registry record.
The analysis plan, including any interim analyses and the approach to multiplicity or missingness, is not reported in the registry record. These gaps limit assessment of whether the reported outcome summaries, where available, were prespecified and how complete the underlying data were.
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 |
|---|---|---|---|
| Assisted Evaluable Period | 5 | 34 | 14.7% |
| Unassisted Home Evaluable Period | 2 | 28 | 7.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Assisted Evaluable Period | 0 of 34 |
| Unassisted Home Evaluable Period | 0 of 28 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Assisted Evaluable Period | 31 of 34 |
| Unassisted Home Evaluable Period | 24 of 28 |
Most frequent serious adverse event terms
| Event term | Organ system | Assisted Evaluable Period | Unassisted Home Evaluable Period |
|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 34 | 1 of 28 |
| Bacteremia | Infections and infestations | 1 of 34 | 0 of 28 |
| Pneumonia | Infections and infestations | 1 of 34 | 0 of 28 |
| Vascular access site thrombosis | Injury, poisoning and procedural complications | 0 of 34 | 1 of 28 |
| Hypervolemia | Metabolism and nutrition disorders | 1 of 34 | 0 of 28 |
| Anxiety | Psychiatric disorders | 1 of 34 | 0 of 28 |
| Acute pulmonary edema | Respiratory, thoracic and mediastinal disorders | 1 of 34 | 0 of 28 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 1 of 34 | 0 of 28 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Assisted Evaluable Period | Unassisted Home Evaluable Period |
|---|---|---|---|
| Muscle spasms | Musculoskeletal and connective tissue disorders | 9 of 34 | 6 of 28 |
| Headache | Nervous system disorders | 8 of 34 | 6 of 28 |
| Diarrhea | Gastrointestinal disorders | 7 of 34 | 5 of 28 |
| Dizziness | Nervous system disorders | 7 of 34 | 4 of 28 |
| Nausea | Gastrointestinal disorders | 6 of 34 | 4 of 28 |
| Hemorrhage | Vascular disorders | 8 of 34 | 2 of 28 |
| Hyperphosphatemia | Metabolism and nutrition disorders | 4 of 34 | 4 of 28 |
| Hypophosphatemia | Metabolism and nutrition disorders | 6 of 34 | 2 of 28 |
| Vomiting | Gastrointestinal disorders | 2 of 34 | 3 of 28 |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | 3 of 34 | 2 of 28 |
Serious events with the highest arm-level rate: vascular access site thrombosis (3.6%), dyspnea (3.6%), bacteremia (2.9%), pneumonia (2.9%), hypervolemia (2.9%).
The registry’s serious adverse-event summary lists the Assisted Evaluable Period as 34 at risk, with 5 affected, and the Unassisted Home Evaluable Period as 28 at risk, with 2 affected. These are period-specific registry figures. They are not treatment rates per 100 treatments, and they should not be interpreted as a randomized comparison. The study is single-group, and the record does not report a statistical comparison or uncertainty interval for these summaries.
The record also lists serious-event terms and percentages: vascular access site thrombosis and dyspnea at 3.6% each; bacteremia, pneumonia, hypervolemia, and anxiety at 2.9% each. The registry record does not report the denominators or counting conventions for these percentages. A listed event term does not, by itself, establish that the device caused the event. It describes an event recorded in the safety summary, not a causal conclusion.
In general, adverse-event summaries require attention to definitions, exposure, repeat events, and the number of participants observed. The primary endpoint uses treatments as its exposure unit, whereas the serious-event summary is presented using at-risk and affected figures. The two types of information answer different questions, and one cannot be used to fill in the missing primary rate.
12. What the Result Does, and Does Not, Mean
The record establishes that a prospective, multicenter, open-label, single-arm study was conducted to gather safety data for nocturnal use of the HemoCare™ Hemodialysis System. It identifies the primary endpoint as adverse events per 100 treatments during assisted and unassisted home evaluable periods, and it gives selected serious adverse-event summaries. These details describe the question and structure of the study, but they are not a complete report of the primary result.
The numerical primary event rate is not reported in the registry record. Neither are the treatment denominators, an uncertainty interval, or an inferential analysis of the primary endpoint. As a result, the registry record does not show the estimated frequency of adverse events per treatment exposure or how precisely that frequency was estimated. The serious-event figures add descriptive information, but without an uncertainty analysis or a randomized comparator they cannot establish comparative risk.
The results also do not establish causation. An adverse event occurring during device use may be related to the device, the underlying condition, other circumstances, or a combination of factors. The record does not report the event-adjudication procedures needed to assess attribution. Likewise, differences between the assisted and unassisted periods, if considered, would not automatically represent effects of assistance, because the periods were not described as randomized comparison groups.
The listed secondary outcomes identify other aspects of safety and clinical observation that the study intended to evaluate. Their numerical results and analysis details are not reported in the registry record. No conclusion about those outcomes should be inferred from their inclusion in the registry.
In general, the strength of a safety conclusion depends on the event definitions, completeness of observation, exposure accounting, precision, and the design’s ability to support comparisons. The registry record provides some design and safety-summary information, but does not report enough to quantify the primary event rate or support a comparative conclusion. This should be understood as a limitation of the information reported in the registry, not as evidence that the underlying study collected no additional data.
13. Why This Trial Matters Statistically
This study highlights a central issue in safety research: an event count and an exposure-based event rate are not the same measure. The primary endpoint is defined per 100 treatments, which makes treatment exposure part of the outcome’s interpretation. Without the number of treatments and the resulting rate, the primary safety question cannot be answered from the registry record alone.
The study also illustrates why design labels matter. Assisted and unassisted periods can organize safety observations across stages of use, but they are not equivalent to randomized groups. A descriptive comparison across periods may be useful for generating questions, yet it does not by itself identify a causal effect. This distinction is especially important when a study has no separate control group.
Another statistical issue is precision. The record lists serious adverse-event summaries and event terms, but does not give uncertainty intervals or the primary event-rate estimate. Statistical interpretation is not only about whether events were recorded; it also asks how much information supports an estimate and how uncertain that estimate remains. A missing interval prevents readers from judging precision, while a missing primary rate prevents assessment of the endpoint’s magnitude.
The record’s outcome list further shows why analysis planning matters. Multiple safety and laboratory outcomes can be informative, but readers need to know which outcomes were primary, how secondary outcomes were handled, and how missing measurements affected the analyses. Those details are not reported in the registry record. A clearly documented analysis plan would help distinguish confirmatory conclusions from descriptive or exploratory summaries.
The record therefore offers a useful example of the gap between identifying a safety endpoint and reporting enough information to interpret it fully. Its design and intended measures are described, but the primary numerical finding and key analysis details are absent from the registry record. Statistical conclusions should remain proportional to that 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 most direct limitation for interpretation is that the registry record does not report the numerical result for the primary adverse-event rate per 100 treatments. It also does not report the treatment exposure denominator or uncertainty interval. Without those elements, the main endpoint cannot be assessed for magnitude or precision.
The study is single-arm and open-label, with no randomized control group. The assisted and unassisted home evaluable periods do not constitute a like-for-like randomized comparison. The record does not describe methods for adjusting for differences between periods, so period-specific summaries should not be read as causal estimates of the effect of assistance or of device use compared with another approach.
The registry record does not report detailed definitions for adverse events, whether repeated events were counted, how events were attributed to treatment, or how event assessment was conducted. It does not provide the denominators or counting rules underlying the listed serious-event percentages. These omissions constrain interpretation of the safety summaries.
The record lists a primary population definition, but does not report the actual analysis population for the primary endpoint, the amount of missing data, or procedures for handling missing observations. It also does not report the statistical analysis plan, sample-size justification, interim analyses, multiplicity approach, or the methods used for any outcome analyses. No analyses are listed in the registry results record.
Finally, the registry describes a study intended to gather safety data, but does not provide the primary estimate needed to characterize the observed event rate. These limitations concern what is reported in the registry record; they do not establish what information may exist outside it.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD — NCT04087213.
- Registry record last updated 2024-08-13; status last verified 2024-01.
- Results first posted 2024-08-13.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
The registry record describes a completed, prospective, multicenter, open-label, single-arm study of the HemoCare™ Hemodialysis System for home nocturnal hemodialysis in people with end-stage renal disease. Enrollment was 36. The study began on 2019-09-05 and its primary completion date was 2023-01-11.
The primary endpoint is adverse events per 100 treatments during the Assisted and Unassisted Home Evaluable Periods, with a stated timeframe of 31 weeks. The record defines the primary population as subjects who used the device at least once during the assisted period. It also lists secondary safety and clinical outcomes.
Serious adverse-event summaries and selected event terms are reported, but the primary event rate, treatment denominators, uncertainty estimates, and detailed statistical analyses are not reported in the registry record. The single-group design does not provide a randomized control comparison.