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 Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload (NCT03359161), a na phase 2, phase 3 study. The primary outcome is Weight Change.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03359161 |
| Phase | Phase 2, Phase 3 |
| Condition | Heart Failure |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Steward St. Elizabeth's Medical Center of Boston, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
People with heart failure and mild to moderate evidence of fluid overload presenting to the cardiology service at St Elizabeth's Medical Center were described as the intended study population. The registry summary gives no further eligibility criteria, so the characteristics of people who qualified, and how closely they represented a broader clinical population, are not reported in the registry record.
Intervention
The intervention was the sc2Wear Furosemide Infusor, a pump delivering a furosemide formulation through the skin. The registry summary describes home use for three days, with possible additional treatment if more therapy was prescribed after evaluation. The arm is described as prospective and open label.
Comparator
There was no comparator group. The record classifies the study as single group, with allocation not applicable and masking absent. The enrolled participants therefore do not provide a concurrent control group for comparing outcomes under another treatment or under no study treatment.
Primary question
The primary outcome was weight change, in pounds, from enrollment or screening to the last observation, assessed over a 30-day timeframe. The study aimed to describe clinical utility in the treatment group. Because the registry record does not report the observed weight-change result, it cannot establish the direction or size of the recorded change, or how precisely it was estimated.
3. Trial Design
The registry lists NCT03359161 as an open-label, descriptive study of subcutaneous furosemide for people presenting with early signs of fluid overload. It lists phase 2 and phase 3, identifies the model as single group, and reports no allocation or masking. The intervention arm is described as prospective. With no comparison arm, the design is suited to describing observations among treated participants, not to separating an intervention effect from changes that could occur for other reasons.
The registry reports enrollment of 9 and a status of terminated. The study start date is 2018-04-05, and the primary completion date is 2019-01-31. The reason for termination is not reported in the registry record. The summary describes home treatment using the sc2Wear Furosemide Infusor, initially for three days, and says further treatment could be prescribed following clinical evaluation. It also describes home nursing visits and follow-up by the cardiology service.
The primary outcome is weight change between enrollment or screening and the last observation, with a 30-day timeframe. It is summarized as a median with a full range, in pounds. Although the registry lists seven outcome measures, the primary outcome result is not reported in the registry record. The record also lists no statistical analyses. It does not describe a comparator, a randomized assignment process, or a masked assessment; those features should not be assumed.
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
| Stage | In-Home Subcutaneous Furosemide Treatment ARm |
|---|---|
| STARTED | 9 |
| Pilot Phase | 9 |
| COMPLETED | 9 |
| NOT COMPLETED | 0 |
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 | In-Home Subcutaneous Furosemide Treatment ARm |
|---|---|---|
| Participants analysed | 9 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 9 |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 3 |
| 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 | 0 |
| Race (NIH/OMB): White | Participants | 9 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 9 |
6. Primary Endpoint
The registry lists the primary outcome as Weight Change, measured over 30 days.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | pounds |
| Endpoint classification | not reduced to a single comparison |
Weight change compares a participant's weight at enrollment or screening with weight at the last observation. The registry specifies pounds as the unit and a 30-day timeframe. This endpoint can describe whether observed weights changed during the study period, but its meaning depends on which observations were available and when the last observation occurred. The registry does not report those participant-level details.
The planned summary is a median and full range. The median describes the middle of the observed values after ordering them, and is less affected by extreme observations than the arithmetic mean. The full range reports the lowest and highest observed values; it conveys the span of recorded changes but can be sensitive to unusual observations. These are descriptive summaries, not by themselves tests of a treatment effect.
Weight is used as an observable measure of change in this study of fluid overload. Interpreting a change as attributable to treatment would require more than a before-and-after description: other influences and the absence of a concurrent comparator matter. The primary outcome's actual median and range are not reported in the registry record, so the observed direction, magnitude and spread cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a small, single-group study and reports enrollment of 9. It does not report the primary weight-change estimate, its full range, or a statistical analysis of that outcome. Consequently, the posted record does not show whether weight tended to increase or decrease, how large the observed changes were, or how variable they were. No conclusion about the magnitude or precision of the primary outcome can be drawn from an estimate that is not reported.
The design also limits what a descriptive result could establish. Every participant in the reported arm received the study intervention, and there was no concurrent comparator. A before-and-after change could reflect treatment, the course of the underlying condition, other care, measurement timing, or other influences. Without a comparison group, these explanations cannot be separated by the study design. Open-label treatment can also affect care and reporting in ways that a masked design is intended to reduce.
The registry reports that the study was terminated, but the reason is not reported in the registry record. Termination alone does not explain whether enrollment, follow-up, outcome collection or analysis was affected. The record lists no statistical analyses and provides no primary outcome result. It is therefore not possible to assess whether the planned endpoint was analyzed as described, whether any adjustment was made, or whether reported estimates were accompanied by uncertainty measures.
Safety entries show 0 participants with serious adverse events among 9 at risk, 0 with other adverse events among 9 at risk, and 0 deaths in the treatment arm. These are reported counts for this study, not proof that adverse events cannot occur. A small exposed group provides limited information about uncommon harms, and the record does not provide event narratives or additional detail on ascertainment.
Any planning illustrations based on an observed effect are hypothetical planning calculations, not evidence about the trial's power or a result from a comparison. The record does not give outcome estimates to interpret, and the study itself has no randomized treatment contrast. The most defensible reading is therefore descriptive: the registry identifies the design, endpoint and safety counts, while leaving the primary efficacy result and its precision unreported.
9. Statistical Methods Explained
Statistical methods should be interpreted in light of the design and the information actually reported. This study is described as single group, prospective and open label. A single-group study can record outcomes after treatment and describe their distribution. It does not, by itself, estimate what would have happened to the same participants without treatment. A difference between an earlier and later measurement is an observed change, not automatically a causal treatment effect.
What does a median and full range describe?
The primary endpoint is summarized using a median and full range. In general, the median is the central observation in an ordered set of values. It can be a useful summary when a distribution is skewed or contains extreme values, because it does not depend on the size of every value in the same way that a mean does. The full range gives the minimum and maximum observed values. It can make the spread visible, but can be strongly affected by extreme observations and does not show how values are distributed between the endpoints.
These summaries are descriptive. They do not automatically provide a confidence interval or a test of whether change differs from zero. A confidence interval, in general, expresses uncertainty around an estimated quantity under specified assumptions; it is not reported for the primary endpoint in the registry record. The record does not report the observed median or range either, so neither the outcome's central tendency nor its spread can be assessed.
Why does the single-group design matter?
In a randomized comparison, treatment groups can provide a basis for estimating differences while reducing some sources of confounding. This study has no comparator and no allocation process. A within-participant comparison of weight at enrollment or screening with weight at the last observation can document change over time, but other influences can also produce change. These may include the natural course of illness, other care, differences in measurement timing, or changes in observation. Without a suitable control group, an observed change cannot identify which explanation accounts for it.
Open-label means the study is not masked. In general, knowledge of treatment can influence participant reports, clinical decisions, or outcome assessment. Weight is a comparatively direct measurement, but the registry does not describe measurement procedures, assessor masking, or quality-control methods. Those details are not reported in the registry record and should not be inferred.
What is known about the analysis plan?
The registry lists seven outcome measures and no statistical analyses. It does not report a statistical analysis plan, a hypothesis test, an adjustment method, a confidence interval, an analysis population, or a missing-data procedure. The absence of a listed analysis does not prove that no analysis took place outside the registry; it means the analysis details are not reported in the registry record. No test or model should be attributed to the study on the basis of the endpoint summary alone.
The primary endpoint uses the last observation within a 30-day timeframe. The record does not say how last observations were selected when participants had different follow-up patterns, whether all participants contributed an endpoint, or how missing measurements were handled. In general, an analysis based on available observations can be biased if the availability of measurements is related to participants' outcomes or health. The amount and pattern of missing data are not reported, so the direction or extent of any such influence cannot be assessed.
How should planning illustrations be read?
The registry's planning description specifies a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. This is a planning framework rather than the design of the single-group trial. The record does not report the resulting planning sample sizes in the registry record for this interpretation. Such calculations are illustrations conditional on their assumptions; they are not observed power and do not establish that the study had an adequate sample size.
More generally, over-dispersion means that observations vary more than a statistical model assumes. When present, ignoring it can make uncertainty look smaller than it is. The registry record does not report a fitted model or an over-dispersion assessment, and the descriptive median and range do not establish that such an issue was evaluated. Statistical methods must therefore be described cautiously: the outcome summary format is stated, but the analysis used to generate results is not reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven outcome measures, but does not report the statistical analyses or explain whether outcomes were tested as a family, assigned a hierarchy, or adjusted for multiple comparisons. When many outcomes are examined, the chance of finding an apparently notable result can increase if each is tested independently. Methods such as prespecifying a primary outcome or adjusting inference can address that issue, but no such approach is reported in the registry record. The primary outcome is identified as weight change; that designation alone does not reveal how other outcomes were handled.
The record does not report missing-data counts, reasons for missing observations, or a missing-data method. It also does not say whether the primary outcome was available for everyone enrolled. The endpoint is defined by the last observation, but the record does not explain how participants without a suitable observation were treated. In general, missingness can affect an estimate when availability is related to the outcome or to participant characteristics; its impact cannot be evaluated without information about the missingness pattern and analysis approach.
The analysis population is not described in the registry record. It is not possible to determine whether the reported enrollment corresponds to the population used for any analysis, or whether exclusions occurred after enrollment. The record lists no statistical analyses, and does not report an intention-to-treat, per-protocol or other analysis set. These are unreported methodological details, not grounds for assuming a particular approach.
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 |
|---|---|---|---|
| In-Home Subcutaneous Furosemide Treatment ARm | 0 | 9 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| In-Home Subcutaneous Furosemide Treatment ARm | 0 of 9 |
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 |
|---|---|
| In-Home Subcutaneous Furosemide Treatment ARm | 0 of 9 |
For the In-Home Subcutaneous Furosemide Treatment arm, the registry reports 9 participants at risk for serious adverse events and 0 affected. It also reports 9 at risk for other adverse events and 0 affected, with 0 deaths. These counts describe what is entered in the registry for this study; they do not establish that the intervention has no risks.
Zero reported events in a small study can coexist with uncertainty about less common harms. The counts cannot estimate the frequency of events beyond the observed study experience, and they do not describe the severity or timing of unreported events. The registry does not list serious-event terms, and does not provide additional event narratives in the record. The methods used to collect and classify safety events are not reported in the registry record.
The at-risk counts are not a comparison with an untreated or alternative-treatment group. With no comparator, the safety entries cannot show whether event risk differs between treatment options. They should be read as recorded observations in the study arm, not as a complete safety profile or a causal estimate.
12. What the Result Does, and Does Not, Mean
The record establishes that an open-label, single-group study evaluated a subcutaneous furosemide infusor in people with early signs of fluid overload. It identifies weight change from enrollment or screening to the last observation over a 30-day timeframe as the primary outcome, with a median and full range as the summary format. It also records enrollment of 9 and reports no serious adverse events, other adverse events or deaths in the listed arm.
Those design and safety details do not provide the missing efficacy result. The primary weight-change estimate and range are not reported in the registry record, so the posted results do not show the direction, size or variability of observed weight change. The record lists no statistical analyses, so it also does not establish how uncertainty was quantified or whether additional analyses were performed.
The single-group, open-label design cannot isolate a treatment effect from other causes of change. There is no randomized or concurrent comparator against which to interpret the endpoint. Even if a before-and-after change were available, it would remain descriptive unless supported by a design and analysis capable of addressing alternative explanations. The record does not report the reason for termination, missing-data handling, or the analysis population, which further limits assessment of completeness and potential bias.
The safety counts are reassuring only in the narrow descriptive sense that no events are recorded in these categories for the exposed group. They cannot rule out uncommon events or establish comparative safety. Taken together, the registry supports a description of the study's intended question, design and recorded safety counts, but not a conclusion about treatment benefit, treatment failure, or comparative safety.
13. Why This Trial Matters Statistically
This study illustrates how the interpretation of an endpoint depends on design as well as measurement. Weight change is a directly interpretable quantity, but a single-group before-and-after endpoint does not reveal what would have happened under a different care strategy. Statistical summaries can describe observed changes; they cannot by themselves remove confounding or create a comparison that the design did not include.
It also highlights the difference between a defined endpoint and a reported result. The registry specifies the weight-change measure, unit, timeframe and summary format, yet does not report the endpoint value. Without the estimate and its spread, readers cannot judge the observed direction, size or precision. A methods description is not a substitute for outcome reporting.
The safety record offers another useful statistical lesson. Zero recorded events in a limited study cohort is an observation, not proof of zero underlying risk. Rare outcomes require more information than a small descriptive study can generally provide, and a comparative safety question requires an appropriate comparator and consistent event ascertainment.
Finally, registry completeness matters for interpretation. The status is terminated, while the reason, analysis details, missing-data approach and analysis population are not reported. Those omissions do not demonstrate a particular problem with conduct or analysis, but they leave important uncertainties unresolved. The case underscores why readers should distinguish what a record directly reports from what a study design could potentially establish.
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 the primary outcome result in the registry record. Although the endpoint is specified as median weight change with a full range, neither summary is reported. The direction and magnitude of the observed change, its distribution and its precision therefore cannot be evaluated.
The study has a single treatment group, no allocation and no masking. Without a comparator, outcome changes cannot be separated from other influences over time. Open-label conduct can also affect reporting, care decisions or assessment. The registry does not report how weight was measured or whether assessments were standardized.
Enrollment was 9, and the record states that the study was terminated. The reason for termination is not reported in the registry record, nor does the record explain whether termination affected enrollment, follow-up or outcome reporting. The analysis population, missing observations, missing-data handling and statistical analysis methods are also not reported. These gaps prevent assessment of potential selection, attrition or analytical biases.
The safety counts report no events in the listed categories, but the study experience is limited and the event-collection procedures are not described. The record lists seven outcome measures but does not report how multiplicity was handled. These limitations restrict what can be concluded from the posted results; they do not establish that unreported outcomes or analyses were unfavorable.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload — NCT03359161.
- Registry record last updated 2022-10-13; status last verified 2021-08.
- Results first posted 2022-10-13.
- 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.
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18. Record Summary
NCT03359161 is listed as a phase 2 and phase 3, prospective, open-label, single-group study of the sc2Wear Furosemide Infusor for people with heart failure and early signs of fluid overload. Enrollment is reported as 9. The study is listed as terminated; its start date was 2018-04-05 and its primary completion date was 2019-01-31.
The primary outcome is weight change in pounds, from enrollment or screening to the last observation over a 30-day timeframe, summarized by median and full range. The primary outcome result and statistical analyses are not reported in the registry record. Safety entries report 0 serious adverse events, 0 other adverse events and 0 deaths in the treatment arm. The reason for termination, analysis population and missing-data methods are not reported.