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 ivWatch Sensor: Device Validation for Infiltrated Tissues (NCT04064229), a na na study. The primary outcome is Red Notification Sensitivity to Infiltrated Tissues.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04064229 |
| Phase | NA |
| Condition | Infiltration of Peripheral IV Therapy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 99 |
| Arms in the primary outcome | n/a |
| Lead sponsor | ivWatch, LLC |
| Results posted | Yes |
2. Clinical Question
Population
Adult volunteers undergoing induced infiltration at peripheral IV sites. The registry record identifies the forearm and the dorsal aspect of the hand as site locations. It lists enrollment as 99, while the brief summary describes 98 adult volunteers; the record does not explain the difference.
Intervention
Monitoring with the ivWatch Model 400, using either the SmartTouch Sensor or the Fiber Optic Sensor. The intervention description says an IV site was monitored during infiltration of 10 mL of isotonic saline solution.
Comparator
No control or comparison intervention is identified. The registry describes a single-group study, and allocation is listed as NA. The two sensor configurations are named as interventions, but the record does not establish a randomized, like-for-like comparison between them.
Primary question
What percentage of infiltrated IV sites received a red notification from the ivWatch Model 400? The primary outcome is defined as the number of infiltrated sites with a red notification divided by the total number of infiltrated sites in the study.
The clinical question is about device detection under the described study conditions, not about comparing treatment outcomes. Infiltrations were limited to 10 mL of isotonic saline solution, and the stated infiltration rate ranged from 5 mL/hr to 150 mL/hr. The primary outcome refers specifically to red notifications. Yellow notifications, infiltrated volume at notification, and skin irritation or disruption to skin integrity are listed as secondary outcomes. The registry record does not report the primary endpoint result, its confidence interval, or results for the secondary outcomes. Consequently, it does not allow the reader to determine the observed notification sensitivity from the record alone.
3. Trial Design
The registry identifies NCT04064229 as a completed, single-group device-validation study of the ivWatch Model 400. Its title is “ivWatch Sensor: Device Validation for Infiltrated Tissues.” The condition is infiltration of peripheral IV therapy. The interventions listed are the Model 400 with a SmartTouch Sensor and the Model 400 with a Fiber Optic Sensor.
The arm description says the sensors monitored an IV site during infiltration of 10 mL of isotonic saline solution. Sites were placed in the forearm and the dorsal aspect of the hand, with infiltration rates ranging from 5 mL/hr to 150 mL/hr. The primary outcome timeframe is after each participant has been infiltrated, for an expected average of 1 hour. The brief summary describes 98 adult volunteers, while the enrollment entry lists 99. The registry record does not explain this difference or specify how many participants contributed data to each outcome.
Allocation is listed as NA, masking as NONE, and the model as SINGLE GROUP. The record therefore does not describe a randomized comparison or identify a separate control group. Although two sensor configurations are listed, they should not be treated as randomized comparison arms on the basis of this record. The study started on 2019-04-03, had a primary completion date of 2019-04-09, and is marked COMPLETED. The listed phase is NA.
The registry record does not report a protocol-level sample-size justification, planned interim analyses, or a detailed statistical analysis plan. It also does not report how the number of infiltrations or the number of sites per participant was determined. These missing details limit assessment of the intended precision and analysis structure.
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 | Infiltrated Tissue |
|---|---|
| STARTED | 99 |
| COMPLETED | 99 |
| 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.
Population: One case study (participant) was rejected and removed from analysis because there was a protocol error where the IV tubing was not properly connected, and the saline was leaked from the tubing rather than injected at the skin site.
| Characteristic | Unit | Infiltrated Tissue |
|---|---|---|
| Participants analysed | 98 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 92 |
| Age, Categorical: >=65 years | Participants | 6 |
| Age, Continuous | years | 41.1 (SD 15.5) |
| Sex: Female, Male: Female | Participants | 62 |
| Sex: Female, Male: Male | Participants | 36 |
| Skin Pigmentation | units on a scale | 1.76 (SD 0.84) |
| Body Mass Index (BMI): Normal (BMI 18.5 to < 25) | Participants | 22 |
| Body Mass Index (BMI): Overweight (BMI 25 to < 30) | Participants | 29 |
| Body Mass Index (BMI): Obese (BMI >= 30) | Participants | 47 |
6. Primary Endpoint
The registry lists the primary outcome as Red Notification Sensitivity to Infiltrated Tissues, measured over After each participant has been infiltrated, an expected average of 1 hour.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of infiltrations detected |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled Red Notification Sensitivity to Infiltrated Tissues. It is expressed as the percentage of infiltrated sites detected: the number of infiltrated IV sites where the Model 400 issued a red notification divided by the total number of infiltrated IV sites in the study. All infiltrations in this endpoint definition were limited to 10 mL of isotonic saline solution.
This outcome is used to describe how often the device issued the specified notification among the infiltrated sites evaluated. It is a detection measure under the study’s conditions, rather than a measure of treatment benefit or a comparison with a control intervention. Its interpretation depends on the number of sites assessed and on how the device’s notifications were recorded and classified. Those operational details are not reported in the registry record.
The registry identifies the endpoint summary as a mean with a 95% confidence interval. A confidence interval describes the precision of an estimate under the statistical method used; it does not by itself establish that the estimate applies to settings beyond those studied. The registry record does not report the observed mean, the confidence-interval limits, or the number of sites contributing to the primary outcome. The endpoint can therefore be described from its definition, but its observed value and precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record provides a clear definition of the primary outcome but does not report its observed value. It describes red notification sensitivity as the percentage of infiltrated IV sites receiving a red notification, with a 95% confidence interval intended to accompany a mean estimate. Neither the estimate nor the interval limits are reported. As a result, the posted record does not show how frequently red notifications occurred or how precisely that frequency was estimated.
This absence also prevents assessment of the endpoint against any target or benchmark. No such target is reported in the registry record. The result cannot be reconstructed from the enrollment entry, the intervention description, or the adverse-event figures. Those entries describe study participation and safety summaries, not the number of infiltrated sites with red notifications.
The study is listed as single-group, with allocation NA and masking NONE. There is no identified control intervention. The two sensor configurations are listed, but the record does not establish that participants or sites were assigned to them in a randomized, comparable way. Accordingly, the record does not support a causal comparison between the SmartTouch and Fiber Optic configurations. Nor does it describe a comparison with usual monitoring or another device.
The study conditions matter when interpreting any detection estimate: the description specifies 10 mL of isotonic saline solution, sites on the forearm and dorsal aspect of the hand, and infiltration rates ranging from 5 mL/hr to 150 mL/hr. These conditions define the context of the assessment. The registry record does not establish how results vary by site location, rate, or sensor configuration.
The enrollment entry lists 99, whereas the brief summary describes 98 adult volunteers. The registry record does not reconcile these counts or report the outcome-specific analysis population. Thus, even the overall enrollment cannot be assumed to be the denominator for the primary endpoint. No primary analysis is listed in the registry record, and the primary endpoint result and interval are absent. Interpretation should therefore remain focused on the stated design and outcome definition rather than on an unreported result.
9. Statistical Methods Explained
What does a confidence interval convey?
General statistical explanation: a confidence interval expresses the uncertainty around an estimate under a specified statistical method and its assumptions. A narrower interval indicates greater precision within that framework, while a wider interval indicates greater uncertainty. The interval does not remove potential bias from study design, measurement, selection, or incomplete reporting. Here, the registry identifies a 95% confidence interval for the primary outcome, but does not report its limits or the associated estimate. Precision therefore cannot be evaluated from the registry record.
What does a detection percentage describe?
General statistical explanation: a detection percentage relates the number of target events detected to the number of target events assessed. In this study’s primary outcome definition, the target events are infiltrated IV sites and the detection is a red notification from the device. A percentage of this kind describes performance within the observed study conditions. It does not, by itself, reveal how often notifications might occur when no infiltration is present, because the registry’s primary endpoint definition does not address that question. The record also does not report the counts that would permit the reader to inspect the estimate directly.
Why does the study structure matter?
General statistical explanation: a control group can provide a basis for estimating differences between interventions when the design and analysis support that comparison. In a single-group study, outcomes are described for the group studied, but a separate control-based treatment contrast is not available unless one is otherwise defined. This record identifies a single-group model and no allocation scheme. The two named sensor configurations do not, on their own, establish a controlled or randomized comparison. Any comparison between them would require details about assignment, participants, sites, and analysis that are not reported in the registry record.
Why can repeated sites affect analysis?
General statistical explanation: when multiple observations come from the same participant, those observations may be statistically related rather than independent. Analysis methods may need to account for that clustering to avoid overstating the amount of independent information. The registry describes infiltrated IV sites and adult volunteers, but does not report the number of sites per participant or how any within-participant dependence was handled. It is therefore not possible to assess whether the analysis treated sites as independent, used participant-level summaries, or applied another approach.
What does over-dispersion mean in general?
General statistical explanation: over-dispersion occurs when observed variability is greater than the variability assumed by a statistical model. If a model does not accommodate that extra variability, uncertainty estimates can be too small. Whether this issue is relevant depends on the data structure and chosen model. The registry record does not identify the model used for the primary endpoint or provide data with which to assess dispersion. No conclusion about over-dispersion in this study can be drawn from the record.
What can a planning illustration tell readers?
General statistical explanation: a sample-size calculation based on an observed effect is a planning illustration of how many participants per arm might be needed under stated assumptions. It is not an observed trial result and is not observed power. The assumptions identified for the planning illustration are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. For non-time-to-event outcomes, the illustration is expressed as participants per arm for 80% power or another stated power level; time-to-event calculations use a total number of events. Those calculations do not convert this single-group validation study into a randomized comparison, and the illustration is not the trial’s own design justification. The registry record does not report a protocol-based sample-size justification.
For this endpoint, the registry states a mean and a 95% confidence interval, but does not report the statistical model, the calculation of the interval, or the handling of missing or repeated site observations. Those omissions prevent a detailed assessment of the primary analysis. The stated endpoint definition and design can be described, while the result and its statistical uncertainty remain unreported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures: the primary red-notification sensitivity outcome and four secondary outcomes. The secondary outcomes concern yellow notification sensitivity, infiltrated volume when a red notification was issued, infiltrated volume when a yellow notification was issued, and significant skin irritation or disruption to skin integrity. The record does not report results for these outcomes.
When a study evaluates multiple outcomes or performs multiple statistical tests, the chance of at least one apparently notable result can increase. General statistical explanation: multiplicity procedures can address this issue by adjusting how evidence is evaluated across a set of tests. The registry record does not report whether multiplicity adjustments were planned, which outcomes were included in any testing family, or whether a hierarchy among outcomes was specified. No conclusion about multiplicity control can be drawn.
The record lists zero analyses. It does not report the primary endpoint estimate, confidence-interval limits, or outcome-specific participant and site counts. The brief summary describes 98 adult volunteers, while the enrollment entry lists 99; no explanation is given. The analysis population is not reported in the registry record.
Missing-data rules, reasons for missing observations, and methods for handling incomplete endpoint measurements are not reported in the registry record. The record also does not state whether all enrolled participants contributed to every outcome or how sites nested within participants were handled. Without those details, readers cannot assess the extent or potential influence of missing data, or determine whether the reported enrollment corresponds to the population used for an outcome analysis. These are reporting gaps, not evidence that data were missing or that a particular method was used.
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 |
|---|---|---|---|
| SmartTouch Sensor | 0 | 99 | 0.0% |
| Fiber Optic Sensor | 0 | 99 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| SmartTouch Sensor | 0 of 99 |
| Fiber Optic Sensor | 0 of 99 |
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 |
|---|---|
| SmartTouch Sensor | 0 of 99 |
| Fiber Optic Sensor | 0 of 99 |
The registry lists separate adverse-event summaries for the SmartTouch Sensor and Fiber Optic Sensor. For each listed sensor group, 99 participants are recorded as at risk for serious adverse events and 99 as at risk for other adverse events. The recorded counts affected are zero for serious adverse events, zero for other adverse events, and zero deaths in each group. No top serious-event terms are listed.
These are counts as recorded in the registry, not evidence that the risk of an event is absent. A zero count means that no events are listed as observed in the relevant summary; it does not establish that an event could never occur. The registry record does not provide additional detail about event collection, event definitions, follow-up completeness, or how participants were assigned to the two sensor summaries.
The same at-risk count appears in each sensor group. The record does not explain whether those group summaries involve distinct participants or overlapping exposure, so the counts should not be added or treated as evidence of separate, independent cohorts. These safety entries also do not provide the primary detection outcome. They should be read as adverse-event counts only, without treating them as a comparison of the sensor configurations or as a substitute for the unreported efficacy endpoint.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was intended to assess the ivWatch Model 400 during induced infiltration at peripheral IV sites. It specifies two sensor configurations, the site locations, the infiltrated volume, the range of infiltration rates, and a primary outcome based on red notifications. Those details define the conditions under which the device was to be evaluated.
The record does not report the primary endpoint estimate or its 95% confidence interval. It therefore does not show the observed percentage of infiltrated sites with a red notification, nor the precision of that estimate. The secondary outcome results are also not reported. The record cannot establish from these entries how often yellow notifications occurred, the volumes at notification, or whether skin irritation or disruption was observed.
The single-group design and lack of a reported control mean that the record does not provide a randomized comparison with another device or monitoring approach. The two sensor configurations are named, but the record does not describe a like-for-like comparative analysis. Conclusions about one configuration relative to the other are not supported by the available design information.
General statistical explanation: a result from a particular set of study conditions does not automatically generalize to other populations, settings, device versions, infiltration volumes, sites, or rates. The registry record does not report analyses of performance across those conditions. The stated conditions should therefore be treated as the scope of the described assessment, not as evidence about every use context.
The adverse-event summaries list zero serious events, zero other events, and zero deaths for each sensor group, with 99 at risk in each. These counts are limited to what the registry records and do not establish that risk is impossible. Overall, the record permits a description of study design, outcome definitions, and the listed safety counts, but not an assessment of the primary detection result or its precision.
13. Why This Trial Matters Statistically
Device-validation studies pose a statistical question that is different from a conventional comparison of treatments: how often does a device identify the target condition under specified test conditions? This study’s primary endpoint is framed as red notification sensitivity among infiltrated IV sites. That definition directs attention to the unit being assessed, the notification rule, and the conditions under which infiltration was induced.
The study description identifies the volume, solution, sites, and range of infiltration rates used. Such details matter because a detection estimate is meaningful only in relation to the circumstances in which it was measured. The registry record does not report subgroup results or explain whether performance was assessed separately by site, rate, or sensor configuration. Those questions cannot be answered from the stated design information alone.
The study is identified as single-group, with no allocation scheme and no control intervention. This distinction matters statistically: descriptive detection performance is not the same as a comparative effect. The presence of two named sensor configurations does not establish a controlled comparison. Readers need assignment and analysis details before interpreting any apparent difference between configurations, and those details are not reported in the registry record.
The record also illustrates why endpoint estimates and uncertainty are both important. It identifies a 95% confidence interval as the intended measure of precision, but reports neither the interval nor the primary estimate. Without those results, the registry establishes what was to be measured, but not the observed performance or how precisely it was estimated. Enrollment and safety counts cannot stand in for the missing detection result.
Finally, the discrepancy between the enrollment entry of 99 and the brief summary’s description of 98 adult volunteers highlights the value of explicit participant accounting. The registry record does not explain the difference or identify the outcome analysis population. Clear reporting of denominators, analysis methods, and endpoint results is essential for judging the strength and scope of a device-validation finding.
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.
A central limitation of the registry record is that it does not report the primary endpoint estimate or its 95% confidence interval. The endpoint is defined, but the observed red-notification sensitivity and its precision cannot be assessed. Results for the listed secondary outcomes are also absent, as are outcome-specific denominators.
The enrollment entry lists 99, while the brief summary describes 98 adult volunteers. The record does not reconcile these numbers, explain whether all enrolled participants were assessed, or state how many sites contributed to the primary outcome. It also does not report the number of sites per participant, which limits assessment of the analysis unit and any within-participant dependence.
The study is described as single-group, with allocation NA and masking NONE. The registry record does not identify a control group or a randomized comparison. Although two sensor configurations are listed, the record does not specify assignment, overlap in exposure, or an analysis comparing them. The record therefore offers no basis for a comparative estimate between the configurations.
The registry does not report a detailed statistical analysis plan, handling of missing data, multiplicity procedures, or a protocol-based sample-size justification. It does not explain how notification readings were classified or how measurements were aggregated across sites. These missing details restrict evaluation of analytic choices and possible sources of uncertainty.
Finally, the described test conditions are specific: induced infiltration of 10 mL of isotonic saline solution at sites on the forearm or dorsal aspect of the hand, with rates ranging from 5 mL/hr to 150 mL/hr. The registry record does not report how results might differ under other conditions. These limitations concern the information available in the registry record and should not be mistaken for findings about unreported data.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: ivWatch Sensor: Device Validation for Infiltrated Tissues — NCT04064229.
- Registry record last updated 2022-06-24; status last verified 2022-05.
- Results first posted 2022-06-24.
- 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
NCT04064229 is listed as a completed, single-group device-validation study of the ivWatch Model 400 for infiltrated peripheral IV tissues. The registry names the SmartTouch Sensor and Fiber Optic Sensor configurations and describes monitoring during infiltration of 10 mL of isotonic saline solution at forearm and dorsal-hand sites. The primary outcome is red-notification sensitivity, defined as the percentage of infiltrated sites receiving a red notification, with a 95% confidence interval specified.
The enrollment entry is 99, while the brief summary describes 98 adult volunteers; the registry record does not explain the difference. It lists zero serious adverse events, zero other adverse events, and zero deaths in each sensor summary. The primary outcome estimate, confidence interval, secondary outcome results, analysis population, and detailed statistical methods are not reported in the registry record.