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 Pilot Study to Evaluate Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients (NCT04733664), a na na study. The primary outcome is Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04733664 |
| Phase | NA |
| Condition | End Stage Renal Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | FAST BioMedical |
| Results posted | Yes |
2. Clinical Question
Population
Patients with end stage renal disease on chronic dialysis and extremely reduced or no kidney function. The study enrolled 10 participants.
Intervention
Visible fluorescent injectate (VFI) measured with the FAST PV Technology. Participants also received iohexol as a measurement comparator.
Comparator
There was no randomized or parallel control group. The study describes measurements using FAST PV Technology and iohexol, including assessments before and after dialysis, but the primary outcome concerns the pre-dialysis measurement.
Primary question
Can plasma volume (PV) and interstitial volume (ISV) be measured quantitatively before dialysis using FAST PV Technology and iohexol in chronic dialysis patients?
The study was framed as a pilot evaluation of the safety, tolerability, and performance of FAST PV Technology. Its primary outcome was the mean PV and ISV measured before dialysis, with results intended to be expressed in milliliters and described using a standard deviation. The registry record specifies a timeframe of 1 day for this outcome.
The intervention description also places measurements around a dialysis session: participants received VFI and iohexol approximately 4 hours before dialysis, then a second dose of each approximately 1 hour after completing dialysis. These paired time points give context to the study’s broader interest in pre- and post-dialysis volumes. They do not turn the primary question into a comparison between randomized treatment groups, because the trial used a single-group design.
The record does not report numerical primary endpoint results, estimates of agreement between the measurement approaches, or results for the post-dialysis measurements. It therefore does not establish from the posted results how closely the methods measured volume or how much volume changed over dialysis.
3. Trial Design
This was a completed, open-label, single-group pilot study sponsored by FAST BioMedical. The registry lists an enrollment of 10 and identifies the condition as end stage renal disease. The study start date was 2020-10-29, and the primary completion date was 2021-03-09. The listed phase and allocation are NA, and masking is listed as none.
All participants were assigned to Cohort 1. The cohort description states that participants received a dose of visible fluorescent injectate (VFI) and a dose of iohexol approximately 4 hours before dialysis, followed by a second dose of each approximately 1 hour after completing dialysis. The intervention is listed as VFI using the FAST PV Technology and classified as a device intervention. The brief summary describes the intended use as estimating plasma and interstitial volumes before and after dialysis and characterizing the extent of volume removal.
A single-group pilot can describe measurements and events observed among enrolled participants, but it does not offer a randomized between-group contrast. The registry record does not describe a separate usual-care group or a randomized comparison. The use of two measurement approaches is part of the study’s measurement question; it should not be mistaken for allocation to competing treatment arms.
The registry lists 8 outcome measures and 0 analyses. It does not report a planned sample size justification, a detailed statistical analysis plan, or a numerical primary outcome result. The reason for choosing an enrollment of 10 is not reported in the registry record. The record marks the study completed, but completion status alone does not supply missing endpoint estimates or establish which analyses were carried out.
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 | Cohort 1 |
|---|---|
| STARTED | 10 |
| COMPLETED | 10 |
| 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 | Cohort 1 |
|---|---|---|
| Participants analysed | 10 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 8 |
| Age, Categorical: >=65 years | Participants | 2 |
| Age, Continuous | years | 58.5 (SD 5.8) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 10 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 |
| 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 | 8 |
| Race (NIH/OMB): White | Participants | 2 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis, measured over 1 day.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns plasma volume (PV) and interstitial volume (ISV) measured before dialysis using FAST PV Technology and iohexol. These are continuous measurements, recorded in milliliters. The registry identifies the summary measure as the mean and the measure of dispersion as the standard deviation, with a timeframe of 1 day.
Volume measurements are relevant to the study’s stated purpose because the technology is intended to quantify fluid compartments around dialysis. A pre-dialysis assessment can describe the volume measured at that point in the treatment schedule. The broader study summary also refers to pre- and post-dialysis measurements and volume removal, but the primary endpoint described in the registry is specifically pre-dialysis.
For a continuous outcome, a mean gives a measure of the group’s central value, while a standard deviation describes the spread of individual measurements around that mean. These summaries can help readers understand both the typical measured volume and how much participant measurements vary. They do not, by themselves, establish measurement accuracy, agreement with another method, or clinical importance. Those questions require suitable estimates and analyses, which are not reported in the registry record.
The registry record does not include the observed mean, standard deviation, participant-level results, or a comparison estimate for this primary endpoint. Consequently, the measurement scale and planned summary are identifiable, but the numerical result and its precision cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the purpose and form of the primary endpoint, but does not report its numerical result. It specifies measurement of pre-dialysis PV and ISV using FAST PV Technology and iohexol, in milliliters, with a mean and standard deviation as the intended summaries. No mean, standard deviation, confidence interval, or other estimate is reported for the endpoint. The posted results therefore do not show the volume values observed in the cohort or the precision of those values.
This distinction matters for a measurement-focused pilot. A stated measurement objective is not itself evidence about how well a device measures volume. Assessing performance would ordinarily require reported measurement results and an appropriate analysis of their relation to a comparator or reference. The registry record does not report a numerical agreement estimate, measurement error, or other analysis that would answer that question. The fact that iohexol was used alongside VFI does not, without results and an analysis, establish the degree of agreement between methods.
The study description includes doses before and after dialysis, and the brief summary discusses understanding pre- and post-dialysis volumes and volume removal. Those details describe the study’s intended scope. The primary endpoint listed in the record is pre-dialysis, and numerical post-dialysis findings or estimates of change are not reported in the registry record. No change should be inferred from the fact that both time points were included in the dosing schedule.
The registry lists an enrollment of 10 in a single group. This is the number enrolled, not a reported count of participants with an available primary endpoint. The number included in an endpoint analysis, any exclusions, and the handling of missing measurements are not reported in the registry record. It is therefore not possible to determine whether the primary endpoint summaries, if calculated, included all enrolled participants.
The record lists 8 outcome measures and 0 analyses, while numerical primary endpoint estimates are absent. These registry entries do not establish whether analyses were conducted but not entered, whether results were unavailable, or whether outcomes were not analyzed. The interpretation should stay with the distinction the record supports: the study was completed, its design and measurement objective are described, and the posted results do not provide the numerical primary endpoint findings.
The safety information is also descriptive. The record reports serious adverse events affecting 3 of 10 participants and other adverse events affecting 8 of 10; it reports no deaths. These counts describe the cohort recorded in the registry. In a single-group pilot, they do not provide a comparative estimate of risk or establish whether an event was caused by the device, the procedure, dialysis, or another factor. The registry does not report those causal assessments.
Overall, the available statistical interpretation is limited by missing endpoint estimates and analytic details. No claim about the accuracy, reliability, or clinical impact of FAST PV Technology follows from the stated endpoint alone. The registry record supports describing what the study set out to measure and the event counts it posted, while leaving the main numerical performance question unanswered.
9. Statistical Methods Explained
The study is a single-group measurement pilot rather than a randomized comparison. That design shapes what statistical summaries can answer. A group mean can describe the observed measurements, and a standard deviation can describe their variability. Neither summary is a treatment-effect contrast. The registry record lists no randomized allocation and no parallel control group, so a between-group treatment comparison is not described.
What does a mean and standard deviation describe?
For a continuous outcome such as volume measured in milliliters, the mean is the arithmetic center of the observations. The standard deviation describes how spread out the individual observations are around that center. A relatively compact spread would indicate that observations are closer to the mean; a wider spread would indicate more participant-to-participant variation. These are general statistical interpretations, not findings about this cohort, because the numerical mean and standard deviation are not reported in the registry record.
Neither summary alone describes uncertainty in the estimated mean. A confidence interval is a range calculated from data and a statistical method to express uncertainty about an estimate. Its width depends on the amount and variability of the data and on the method used. No confidence interval for the primary endpoint is reported. Without the numerical estimate, its variability, and the analysis details, the precision of the cohort mean cannot be evaluated.
What would a comparison of measurement methods require?
The study description includes both FAST PV Technology and iohexol. When two approaches measure the same quantity, a useful performance analysis needs to characterize how the paired measurements relate. Correlation, for example, describes whether values tend to vary together, but high correlation alone does not prove that two methods yield similar values. Agreement analyses instead focus on the size and pattern of differences between paired measurements. These are general concepts; the registry record does not report a correlation, paired differences, agreement limits, or another numerical comparison for this study.
The protocol description states that participants received both agents before and after dialysis. That schedule creates the possibility of paired observations at different times, but it does not itself specify which statistical model or comparison was used. The analysis method for repeated measurements, and whether pre- and post-dialysis values were compared statistically, are not reported in the registry record.
How should a single-group pilot be interpreted?
A pilot study can provide descriptive information about measurements and observed events in a small cohort. It can also inform later study planning, but it cannot supply a randomized estimate of comparative treatment effects when no control group is present. A within-participant comparison across time may address change in measurement, but it requires reported data and an analysis that accounts for paired observations. Such estimates are not reported in the registry record.
The registry’s enrollment of 10 is the planned or recorded enrollment figure; the record does not identify how many participants contributed data to each outcome analysis. The distinction between enrolled participants and analyzed participants matters because incomplete measurements, withdrawal, or other exclusions can affect the available data. The reason for any difference between enrollment and analysis counts is not reported in the registry record.
What do the planning assumptions mean?
The registry includes general assumptions for a sample-size planning illustration: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. Those are assumptions for a planning calculation, not a description of the design actually used: this trial is listed as single group, with no randomized allocation. No numerical sample-size illustration is included in the registry record, and no observed effect estimate is reported from which such an illustration could be interpreted.
A planning sample size estimates how many participants might be needed under specified assumptions. It is not an observed study result and does not show the probability that the completed study detected an effect. In particular, it should not be read as observed power. The registry does not report the trial’s own sample-size justification, so it is not possible to determine whether the enrollment of 10 came from a formal calculation, a feasibility target, or another rationale.
Over-dispersion is a general concern when observed variability exceeds what a statistical model assumes. In count outcomes, for example, a model that assumes variability too small can understate uncertainty and make evidence appear more precise than it is. This study’s primary endpoint is continuous, and the registry record does not report an over-dispersion analysis or a fitted model. The concept therefore does not provide a result about this study; it illustrates why model assumptions should be matched to the outcome and checked against data.
Which analysis details are unavailable?
The registry record does not report a statistical analysis plan, a primary endpoint estimate, a confidence interval, a test statistic, or a p-value. It also does not report the analysis population, the handling of missing values, or details of adjustment for multiple outcomes. Those omissions limit reproducibility and prevent readers from assessing whether the reported summaries correspond to a prespecified approach. With no numerical endpoint results posted, statistical significance or precision cannot be inferred.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 8 outcome measures, but does not report an analysis plan describing how results across those outcomes were to be interpreted. It does not state whether one outcome was designated as the sole confirmatory test, whether comparisons were considered exploratory, or whether any adjustment for multiple testing was planned. A multiplicity procedure is not reported in the registry record.
Multiplicity matters when several hypotheses are tested: the chance of at least one apparently unusual result can increase as more tests are considered. This is a general statistical issue, not a statement that any particular analysis in this study was significant. The number of listed outcome measures alone does not tell readers how many statistical tests were performed, which measures were analyzed, or whether any adjustment was used. The record lists 0 analyses, and does not provide test results.
Missing-data methods and analysis populations are also not reported in the registry record. Although enrollment is listed as 10, the record does not say how many participants had measurements available for each outcome, whether any observations were excluded, or how incomplete pre- or post-dialysis measurements were handled. It also does not define an intention-to-treat, per-protocol, or other analysis population. These omissions prevent assessment of whether missingness could have influenced the reported summaries, which themselves are not posted.
The absence of these details should not be interpreted as proof that data were missing or that no multiplicity or missing-data decisions were made. It means the registry record does not describe those methods. Consequently, the analytic scope and robustness of any unposted results cannot be evaluated 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 |
|---|---|---|---|
| Cohort 1 | 3 | 10 | 30.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort 1 | 0 of 10 |
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 |
|---|---|
| Cohort 1 | 8 of 10 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort 1 |
|---|---|---|
| Volume Overload | Vascular disorders | 2 of 10 |
| Gastrointestinal Bleed | Gastrointestinal disorders | 1 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1 |
|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | 2 of 10 |
| Nausea | Gastrointestinal disorders | 1 of 10 |
| Viral Syndrome | Infections and infestations | 1 of 10 |
| Leg Pain | Musculoskeletal and connective tissue disorders | 1 of 10 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 10 |
| Hypotension | Vascular disorders | 1 of 10 |
| Dizziness | General disorders | 1 of 10 |
| Clotted Fistula | General disorders | 1 of 10 |
| Fistula Pseudoaneurysm | General disorders | 1 of 10 |
| Volume Overload | Vascular disorders | 1 of 10 |
Serious events with the highest arm-level rate: volume overload (20.0%), gastrointestinal bleed (10.0%).
The registry reports that serious adverse events affected 3 of 10 participants in Cohort 1. Other adverse events affected 8 of 10 participants, and deaths were recorded as 0. These are counts for the study cohort as posted in the registry record. They are descriptive summaries, not comparisons with another group.
The listed serious adverse event terms include Volume Overload at 20.0% and Gastrointestinal Bleed at 10.0%. The registry’s term-level entries should be read as recorded event categories, not as evidence that the device caused those events. The record does not report event-level attribution, timing, duration, severity grading beyond the serious classification, or a comparison of event rates with a control group. The listed terms may not represent every event category in the study.
Serious adverse events and other adverse events are distinct registry summaries, and the affected-participant counts should not be added together. The record does not state whether a participant could contribute to both categories or whether individuals experienced multiple events. A single-group pilot with 10 enrolled participants can describe what was recorded, but these figures cannot establish comparative safety or a causal relationship.
12. What the Result Does, and Does Not, Mean
The study addresses an important measurement question: whether FAST PV Technology can quantify plasma and interstitial volumes in chronic dialysis patients around a dialysis session. The registry describes administration of VFI and iohexol before and after dialysis, and identifies pre-dialysis volume measurement as the primary endpoint. Those details explain the study’s aim and measurement context.
The posted results do not include numerical primary endpoint values. Without the mean PV and ISV, their standard deviations, or estimates comparing FAST PV Technology with iohexol, readers cannot judge the measured volumes or the precision and agreement of the methods. The study description therefore establishes what investigators intended to assess, but the registry record does not provide the result needed to evaluate that performance question.
The record also does not report numerical post-dialysis findings or a quantified change in volume. The dosing schedule and stated interest in volume removal do not establish how much volume changed in the observed cohort. Any such conclusion would require posted measurements and an appropriate analysis.
The safety figures provide a limited descriptive account: serious adverse events affected 3 of 10 participants, other adverse events affected 8 of 10, and deaths were 0. With no comparator and no reported causal attribution, those counts do not estimate the excess risk associated with the device or establish that an event was caused by it. Nor do they establish safety beyond the cohort and observation reported.
The registry marks the study completed and lists 10 enrolled participants, 8 outcome measures, and 0 analyses. Those administrative and design details should not be confused with a complete report of statistical findings. The reason for the sample size, the analysis population, missing-data handling, and multiplicity methods are not reported in the registry record. The most defensible conclusion is therefore narrow: the study was designed as a single-group pilot to evaluate volume measurement and safety, while the posted registry results do not provide numerical endpoint evidence to assess measurement performance.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it asks a measurement question in a clinical setting where volume estimates are central to the stated purpose of the technology. The protocol description includes measurements before and after dialysis and the use of both VFI and iohexol. Such a study can be informative only when the measurements and their uncertainty are reported clearly, and when the method used to compare them matches the measurement question.
The single-group design is also important to interpretation. It can describe observed measurements and adverse events, but it does not provide a randomized control-group contrast. For a device intended to measure volume, evidence about agreement with a comparator would be more directly relevant than a treatment-effect comparison, but the registry record does not report that analysis. This distinction helps prevent the study’s use of two measurement approaches from being mistaken for a controlled trial.
The record’s lack of numerical primary results is a substantive limitation. Naming a mean and standard deviation as the intended endpoint summaries does not allow readers to evaluate either the central measurements or their variability. Nor can the precision or agreement be assessed without estimates and uncertainty measures. This makes transparent reporting especially important in a pilot whose stated purpose includes performance evaluation.
There is also a difference between a pilot’s feasibility role and confirmatory evidence. A pilot may help characterize procedures and inform future research, but the registry does not report a sample-size rationale or analysis plan that would clarify its intended inferential role. Its enrollment of 10 should not be interpreted as proof of adequate power or as evidence that a clinically meaningful question was conclusively answered.
The registry record thus illustrates why study design, endpoint definition, analytical detail, and complete results need to be considered together. The research question is identifiable, but the posted numerical results do not permit a statistical assessment of the primary measurement objective.
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 main limitation for interpretation is that the registry record does not report numerical primary endpoint results. It describes mean PV and ISV measurement before dialysis, in milliliters, but gives no mean, standard deviation, confidence interval, or participant-level values. The precision of the measurements and the spread across participants therefore cannot be assessed.
The record also does not report a numerical comparison between FAST PV Technology and iohexol. Although both are included in the study description, no estimate of agreement, measurement error, or association is posted. The post-dialysis measurements and any quantified pre-to-post change are also absent. Consequently, the study’s broader stated interest in volume removal cannot be evaluated using posted numerical findings.
The single-group design limits conclusions to descriptions of the cohort and does not permit a randomized comparison with a control group. The record does not report how the study’s sample size was chosen, whether the enrollment of 10 reflected a feasibility objective, or whether a sample-size calculation was conducted. The planning assumptions listed for illustrations do not establish the trial’s own design rationale.
Important analysis details are not reported in the registry record: the analysis population, the handling of missing measurements, the statistical plan, the approach to multiple outcomes, and the methods used for repeated measurements. The record lists 8 outcome measures and 0 analyses, but does not explain the status of analyses or the availability of data for each outcome. These omissions make it difficult to assess reproducibility or selective reporting.
Safety interpretation is similarly constrained by the absence of a comparison group and of reported causal attribution. The posted event counts can describe the cohort, but cannot identify whether events were related to the device or distinguish the device’s contribution from other clinical circumstances.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pilot Study to Evaluate Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients — NCT04733664.
- Registry record last updated 2023-02-08; status last verified 2023-01.
- Results first posted 2022-04-01.
- 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
The registry describes a completed, open-label, single-group pilot study sponsored by FAST BioMedical, with 10 participants with end stage renal disease. The study evaluated VFI using FAST PV Technology, with iohexol measurements, in patients receiving chronic dialysis. Doses were described before and after dialysis.
The primary endpoint was pre-dialysis plasma and interstitial volume, measured in milliliters and intended to be summarized by a mean and standard deviation over a timeframe of 1 day. The registry lists 8 outcome measures and 0 analyses. It does not report numerical primary endpoint results, a sample-size justification, or detailed statistical methods.
For safety, the record reports serious adverse events affecting 3 of 10 participants, other adverse events affecting 8 of 10, and 0 deaths. Serious event terms listed include Volume Overload at 20.0% and Gastrointestinal Bleed at 10.0%. Because the study has no control group and causal attribution is not reported, these event counts are descriptive.