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 Application of the Apsara Thermal Wand System (NCT00662389), a non-randomized early/phase 1 study. The primary outcome is Serious Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00662389 |
| Phase | EARLY/Phase 1 |
| Condition | Tightening of Skin Laxity |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Apsara Medical Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The study summary describes an initial assessment in human facial tissue and lists tightening of skin laxity as the condition. Eligibility criteria and further participant characteristics are not reported in the registry record, so the population cannot be characterized more specifically.
Intervention
The intervention is the Apsara Thermal Wand System, recorded as a device. The summary describes the study as seeking an initial assessment of acute safety and performance. Device-use details are not reported in the registry record.
Comparator
No comparator group is listed. The design is recorded as single group and non-randomized, so the study does not provide a like-for-like control comparison.
Primary question
The listed primary outcome asks for the immediate number of serious adverse events. This addresses an acute safety question, while the broader stated interest in performance is not represented by a separate listed outcome measure.
The registry summary frames the work as a feasibility study for an initial assessment. That framing matters: the question is not whether outcomes differ between randomized groups, because no randomized comparator is recorded. Rather, the available design information describes one group receiving the device and an immediate count of serious adverse events as the primary endpoint.
The record does not report participant eligibility criteria, the procedure used to apply the device, or a detailed definition of the study population. It also does not report a numerical result for the primary outcome. Consequently, the registry information does not establish how many serious adverse events occurred, or whether the broader performance aim was assessed by another measure. Those omissions limit the clinical question that can be answered from the posted results.
3. Trial Design
This is a completed pilot study titled “Application of the Apsara Thermal Wand System,” with the official title “TP-1013 Pilot 1: Application of the Apsara Thermal Wand System.” The registry records the phase as EARLY PHASE1, the allocation as NON RANDOMIZED, the masking as NONE, and the model as SINGLE GROUP. Enrollment is recorded as 4. The sponsor is Apsara Medical Corporation.
The study period is recorded as starting in 2008-04, with primary completion in 2009-03. Its status is COMPLETED. These dates describe the registry record; they do not by themselves provide information about the timing of individual procedures, follow-up, or data collection beyond the primary outcome’s stated immediate timeframe. Such details are not reported in the registry record.
The intervention is the Apsara Thermal Wand System, classified as a device. The registry summary says the feasibility study aimed to gain an initial assessment of acute safety and performance in human facial tissue. The listed condition is tightening of skin laxity. No additional arm description, treatment procedure, or allocation detail is reported in the registry record.
Because the study is single-group and non-randomized, its design does not support a direct treatment-versus-control contrast. The lack of masking is also part of the recorded design, although the registry does not describe who knew the treatment assignment or how outcome assessment was conducted. The registry lists one outcome measure and no analyses. It does not report a statistical analysis plan, sample-size justification, or details of the analysis population. The design should therefore be read as a small pilot record with limited information for comparative or inferential conclusions, rather than as a controlled efficacy comparison.
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 | A--Thermal Wand Application |
|---|---|
| STARTED | 4 |
| COMPLETED | 4 |
| 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 | A--Thermal Wand Application |
|---|---|---|
| Participants analysed | 4 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 |
| Age, Categorical: >=65 years | Participants | 1 |
| Age Continuous | years | 61.7 (SD 3.6) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Serious Adverse Events, measured over Immediate.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Number of Serious Adverse Events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of serious adverse events, with the unit also stated as number of serious adverse events and the parameter described as NUMBER. Its timeframe is Immediate. In general, a count endpoint records how many events occur within a defined observation period; it is not the same as a count of participants unless the outcome definition explicitly says so. Here, the registry defines the outcome as the number of serious adverse events, not the number of participants experiencing an event.
A serious-adverse-event count is used to describe an important aspect of safety. The immediate timeframe indicates that the endpoint concerns events in the immediate period, but the precise operational definition of that period is not reported in the registry record. The registry also does not provide further criteria for classifying an event as serious, or explain how events were identified and adjudicated.
The study summary states a broader aim of assessing acute safety and performance. The listed primary endpoint addresses safety through event counting. No separate performance endpoint is listed among the outcome measures in the registry record, and a performance result is not reported there. The actual number of serious adverse events is also not reported in the registry record. Thus, the endpoint definition can be described, but the observed outcome cannot be characterized from the registry information available.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a completed, early-phase pilot of the Apsara Thermal Wand System with enrollment recorded as 4. Its design is single-group, non-randomized, and unmasked. The primary endpoint is the immediate number of serious adverse events. These details establish the type and scope of the study, but they do not provide the endpoint result itself: the number of serious adverse events is not reported in the registry record.
That absence is central to interpretation. It would be inappropriate to infer that no serious adverse events occurred, or to infer that any particular number occurred. The registry lists one outcome measure and no analyses. Without a posted result, there is no event count to describe, no estimate of uncertainty to interpret, and no basis for judging how precisely the study characterizes acute safety.
Even if a count were available, a single-group pilot would primarily describe observed events in the studied group. It would not, by itself, separate events associated with the device from events that might occur for other reasons, nor would it establish a comparative effect against an untreated or alternative-treatment group. A control comparison is not part of the recorded design. This is a general limitation of interpreting uncontrolled observations, not a finding about this device.
The summary also names performance as an aim, but the registry lists no separate performance outcome among its one outcome measure. The record therefore does not permit a statistical interpretation of performance. The listed safety endpoint and the broader objective should not be treated as interchangeable: an event count does not quantify performance unless a corresponding performance measure is defined and reported.
The enrollment figure indicates the scale recorded for this pilot, not the precision of any result. Since no outcome value or analysis is reported, the degree of statistical uncertainty cannot be assessed. No confidence interval, statistical test, or model result is reported in the registry record. Any planning illustration based on an observed effect would also require an observed effect estimate; it cannot supply the missing trial result or serve as observed power.
Overall, the posted information supports a description of the study’s purpose, design, endpoint, and recorded status. It does not support a conclusion about the observed frequency of serious adverse events, the performance of the device, or a causal effect. The appropriate interpretation is therefore limited to what the registry records, with the primary outcome result remaining unreported.
9. Statistical Methods Explained
What does a count endpoint represent?
In general, a count endpoint represents the number of events observed under a stated definition and during a specified observation period. The outcome in this study is the number of serious adverse events, and its timeframe is Immediate. The count refers to events, not necessarily to people: one person could in principle contribute more than one event, depending on the outcome rules. The registry record does not specify whether repeat events were counted separately or how such cases were handled.
Count outcomes are distinct from continuous measurements, such as a measured change on a scale, and from binary outcomes, such as whether a participant experienced at least one event. A count can be zero or can take higher values, but those general properties do not reveal the observed value in a particular study. Here, the actual event count is not reported in the registry record.
Why does the observation period matter?
An event count depends on how long and how consistently events are observed. A count over an immediate period addresses a different observation window from a count collected over longer follow-up. The stated timeframe helps define the intended scope of the endpoint, but the registry does not provide a detailed operational definition of “Immediate,” the exact duration of observation, or the procedures used to capture events. Therefore, the time window cannot be described more precisely.
In general, counts can sometimes be interpreted in relation to exposure time, but doing so requires a defined time-at-risk denominator and an analysis designed for rates. The registry describes this endpoint as a number of events, not as an event rate, and does not report exposure-time information. A rate interpretation is therefore not supported by the posted record.
What does over-dispersion mean for counts?
As a general statistical concept, a count model may make assumptions about how variable event counts are across observational units. Over-dispersion occurs when the variation is greater than a model’s assumptions allow. If it is present and not accommodated, estimated uncertainty can be too small. Evaluating it requires data and a specified model. Neither a count distribution nor an analysis model is reported in the registry record, so over-dispersion cannot be assessed for this study.
Different analytical approaches can be appropriate for count outcomes depending on the study design, the distribution of counts, the observation period, and the question being asked. No particular approach should be attributed to this trial: the registry lists no analyses, and a statistical analysis plan is not reported in the registry record. The general discussion of count methods does not imply that any such method was used.
What can a single-group design estimate?
In general, a single-group study can describe outcomes observed among its participants. Without a concurrent comparator, it cannot directly estimate a contrast between the device and another treatment or no treatment. Non-randomized allocation also means that the record does not describe random assignment. For this study, the registry specifically records a single-group, non-randomized design and identifies no control arm.
A descriptive count, if reported, would still need to be interpreted in light of the number of observations, outcome ascertainment, and the study’s population and follow-up. The registry records enrollment as 4, but does not report the analysis population or whether all enrolled participants contributed to the endpoint. No adjustment method, confidence interval, hypothesis test, or model estimate is reported. Accordingly, no inferential result can be reconstructed from the posted registry information.
What do planning illustrations mean?
In general, sample-size planning uses assumptions about the effect to detect, variability, significance level, power, allocation, and analysis method. A planning illustration is a hypothetical calculation under stated assumptions; it is not an observed study result and is not observed power. The registry record does not report a trial-specific sample-size justification. It also lists no analysis from which a trial-specific observed effect could be read. Any planning assumptions should therefore not be mistaken for evidence about the study’s findings or design rationale.
The distinction between planned sample size and observed enrollment is important. Enrollment is recorded as 4, while a sample-size justification is not reported in the registry record. The posted record does not explain why that enrollment was selected, whether enrollment met a target, or whether any formal power calculation informed the study. Those points cannot be inferred from the pilot label or from the study’s stated purpose.
In summary, the endpoint is a count with an immediate timeframe, but the count result, detailed endpoint rules, analysis population, and statistical methods are not reported in the registry record. General principles of count analysis explain what information would matter for interpretation; they do not fill in those missing trial-specific details.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure: the immediate number of serious adverse events. It lists no analyses. A multiplicity adjustment or strategy for handling multiple statistical tests is not reported in the registry record. Since the record does not identify a set of analyses or tests, it is not possible to determine whether multiplicity was relevant to the study’s analysis or how it was handled.
The study summary describes both acute safety and performance as areas of interest. However, the registry lists only the serious-adverse-event count as an outcome measure. It does not report a separate performance endpoint or explain whether other measures were collected but not listed. The relationship between the broader study aim and the listed endpoint is therefore not fully described.
Missing-data procedures are not reported in the registry record. The record does not state whether any endpoint data were missing, how missing observations would be handled, or whether follow-up was complete for the immediate timeframe. The analysis population is also not reported, so the relationship between enrollment and any analyzed population cannot be assessed.
These omissions do not establish that data were missing, that additional outcomes were analyzed, or that multiplicity adjustments were required. They mean only that the registry information does not describe those matters. With no reported analysis and no posted endpoint result, there is no basis for evaluating the handling of missing data, the analysis set, or multiplicity in the trial’s results.
11. What the Result Does, and Does Not, Mean
The registry record establishes that this was a completed, single-group pilot of the Apsara Thermal Wand System, with enrollment recorded as 4 and an immediate serious-adverse-event count as the primary endpoint. It also records a broader aim of assessing acute safety and performance in human facial tissue. These registry entries describe the study’s scope; they do not establish what the outcome was.
The number of serious adverse events is not reported in the registry record. As a result, the posted information does not show whether any events occurred or how many occurred. It cannot be used to characterize the observed acute safety outcome or its precision. The absence of a reported count must not be interpreted as a count of zero.
The design also limits what a result could mean. In general, a single-group study without a comparator can describe what was observed in that group, but it cannot make a direct randomized comparison or isolate a treatment effect from other influences. No comparative conclusion is supported by this record. The absence of masking is recorded, but details about outcome assessment are not reported.
Performance is part of the stated purpose, yet no separate performance outcome is listed among the registry’s one outcome measure. The record therefore does not provide a performance estimate. Nor does it report a confidence interval, test, or other analysis that would quantify uncertainty around the primary endpoint.
These limits do not negate the study’s role as a pilot; they define the claims that can be drawn from the posted information. The registry supports a description of the design and endpoint, but not a conclusion about event frequency, comparative effects, or performance.
12. Why This Trial Matters Statistically
Pilot studies can be statistically informative when their question, measurements, and analysis are reported clearly. This registry record is useful for identifying the intended scope: an initial assessment of acute safety and performance for a device in human facial tissue, with the immediate number of serious adverse events as the listed primary endpoint. It also makes clear that the design is single-group, non-randomized, and unmasked.
Those design features are important when interpreting any reported outcome. In general, a single-group count can describe observations in the studied group, while a controlled comparison addresses a different question. Recognizing that distinction prevents a descriptive pilot from being read as a randomized estimate of comparative effect. Here, no control comparison is listed.
The record also illustrates why outcome reporting matters. A precisely named endpoint is not enough to assess a result if its observed value and analysis are not reported. Without the event count, readers cannot evaluate the magnitude of the observed outcome or its statistical uncertainty. The broader performance aim is likewise difficult to assess because no separate performance measure is listed.
Finally, distinguishing enrollment from analysis information matters in small pilot records. The registry records enrollment as 4, but does not report the analysis population, missing-data handling, or statistical methods. These gaps restrict reproducibility and interpretation. The statistical significance of the record is therefore primarily methodological: it shows which design details are documented and which information is needed before drawing conclusions from an outcome.
13. 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 registry record provides limited detail about eligibility and participant characteristics. Although it identifies tightening of skin laxity as the condition and describes human facial tissue as the setting for the initial assessment, it does not report further population characteristics. The findings therefore cannot be placed in a more specific participant context from the registry information.
The intervention is named as the Apsara Thermal Wand System, but application procedures and treatment details are not reported in the registry record. The record also does not give a detailed definition of the immediate observation period or criteria for classifying serious adverse events. These omissions constrain understanding of how the endpoint was measured.
Enrollment is recorded as 4, and the design is single-group and non-randomized, with no masking. A comparator is not listed. These features limit the scope for comparative interpretation. The registry lists one outcome measure and no analyses; it does not report the endpoint value, a confidence interval, or a statistical test. The stated performance aim is not accompanied by a separate listed performance measure.
Other details relevant to interpretation are not reported in the registry record, including an analysis population, missing-data procedures, a statistical analysis plan, and a sample-size justification. These are reporting limitations: the record does not establish that particular procedures were absent from the conduct of the study, only that they are not described in the registry information. Most importantly, the primary outcome result itself is not reported, so the observed acute safety outcome cannot be assessed.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Application of the Apsara Thermal Wand System — NCT00662389.
- Registry record last updated 2009-08-28; status last verified 2009-07.
- Results first posted 2009-08-28.
- 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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17. Record Summary
The registry record identifies NCT00662389 as a completed early-phase 1 pilot titled “Application of the Apsara Thermal Wand System.” Its official title is “TP-1013 Pilot 1: Application of the Apsara Thermal Wand System.” Apsara Medical Corporation is listed as sponsor. The recorded study start is 2008-04, and primary completion is 2009-03.
The design is recorded as non-randomized, unmasked, and single-group, with enrollment of 4. The listed condition is tightening of skin laxity, and the intervention is the Apsara Thermal Wand System, classified as a device. The summary describes an initial assessment of acute safety and performance in human facial tissue.
The sole listed outcome measure is the immediate number of serious adverse events. No analysis is listed, and the outcome result is not reported in the registry record. A separate performance outcome, analysis population, and statistical analysis plan are also not reported.