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 The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe (NCT01389232), a na na study. The primary outcome is Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01389232 |
| Phase | NA |
| Condition | Soft Tissue Support and Repair |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 104 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sofregen Medical, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
People undergoing breast reconstruction surgery in the European post-market study. The registry describes the primary endpoint population as participants with a Month 6 visit; 12 subjects exited the study before Month 6.
Intervention
SeriScaffold® Surgical Scaffold, implanted during breast reconstruction surgery for soft tissue support and repair.
Comparator
There was no comparator group in the registry design. It is recorded as a single-group study, with allocation listed as NA and masking listed as NONE.
Primary question
What was investigator satisfaction with the scaffold after stage I surgery or implantation at Month 6, measured on an 11-point scale from very dissatisfied to very satisfied?
The clinical question is descriptive: it concerns investigators’ reported satisfaction with use of the scaffold in the study population, rather than a comparison of outcomes between treatments. The registry lists the study as a post-market study of the device’s use in breast reconstruction surgery for soft tissue support and repair.
The primary endpoint is one part of a broader set of recorded outcomes. Secondary measures include investigator assessment of ease of use, breast anatomy measurements, and subject satisfaction with breasts. The registry record does not give numerical results for these outcomes or for the primary endpoint. It therefore does not allow a reader to determine the observed level of investigator satisfaction or how that measure varied among participants.
3. Trial Design
This is a completed, single-group, post-market study of the SeriScaffold® Surgical Scaffold in breast reconstruction surgery in Europe. The listed condition is soft tissue support and repair. The intervention description says participants undergoing breast reconstruction surgery were implanted with SERI® Surgical Scaffold. The registry lists Sofregen Medical, Inc. as sponsor.
The study began in 2011-06, reached primary completion in 2013-08, and has status COMPLETED. Enrollment is recorded as 104. The phase is listed as NA. The design fields identify a single-group model, allocation as NA, and masking as NONE. Those entries do not describe a randomized comparison, and the record does not identify a separate control arm. Consequently, the study is not a like-for-like treatment comparison.
The primary measure is investigator satisfaction at Month 6 after stage I surgery or implantation. Its stated population is all participants with a Month 6 visit. The record notes that 12 subjects exited the study prior to Month 6, but does not state the number who contributed primary endpoint measurements or explain the reasons for exit.
Other listed outcomes cover investigator satisfaction and ease of use, breast anatomy, and subject satisfaction with breasts. The registry records five outcome measures, while the analysis count is 0. No numerical primary outcome estimate, variability estimate, confidence interval, or analysis result is reported in the registry record. Details such as eligibility criteria, recruitment procedures, study sites, and the statistical analysis plan are not reported in the registry record.
The design supports description of outcomes among participants with available measurements, but by itself cannot separate device-related changes from other influences or establish a comparative effect. Interpretation should therefore stay close to the study’s stated purpose and the information actually recorded.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Enrollment was defined as having signed the IRB-approved Informed Consent Form. 104 participants were enrolled, of which 100 were implanted with SERI® Surgical Scaffold and are presented in the participant flow.
Overall Study
| Stage | SeriScaffold® Surgical Scaffold |
|---|---|
| STARTED | 100 |
| COMPLETED | 81 |
| NOT COMPLETED | 19 |
Reasons for not completing this period:
| Reason | SeriScaffold® Surgical Scaffold |
|---|---|
| Had scaffold removed | 15 |
| Personal reasons | 2 |
| Adverse Event | 1 |
| Death | 1 |
Analysis population for the primary outcome, as defined in the registry: All participants with a Month 6 visit. 12 subjects exited the study prior to Month 6.
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: Subjects implanted with SERI® during their Stage I breast reconstruction surgery
| Characteristic | Unit | SeriScaffold® Surgical Scaffold |
|---|---|---|
| Participants analysed | 100 | |
| Age, Continuous | Years | 44.7 (SD 10.4) |
| Sex: Female, Male: Female | Participants | 100 |
| Sex: Female, Male: Male | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale, measured over Month 6.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Scores on a Scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is investigator satisfaction with the Seri® Surgical Scaffold at Month 6. It is measured after stage I surgery or implantation using an 11-point scale, with 0 representing very dissatisfied and 10 representing very satisfied. The registry describes the summary measure as a mean and identifies standard deviation as its dispersion measure.
A satisfaction scale captures an investigator’s overall assessment of the device in the context of its use. Such a measure can provide a structured account of user experience, complementing clinical or anatomical measures. The endpoint is not itself a direct measurement of breast anatomy, subject satisfaction, or a comparative clinical outcome. Its meaning depends on the stated scale anchors and the recorded assessment time.
In general, a mean gives the central level of scores across observations, while a standard deviation describes how spread out individual scores are around that mean. The registry record does not report the observed mean or standard deviation for this endpoint. It also does not report a confidence interval, the distribution of scores, the number of Month 6 assessments, or the amount of missing endpoint data beyond noting the prior exits. The endpoint’s numerical result and precision therefore cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a completed single-group study, but it does not report the numerical result for its primary endpoint. Although investigator satisfaction at Month 6 is identified as the primary measure, no mean score or standard deviation is posted in the registry record. The record also lists no analyses. There is therefore no reported estimate to interpret, and no basis in the registry record for describing the level or precision of investigator satisfaction.
The primary population is described as participants with a Month 6 visit. The record notes that 12 subjects exited before that visit. It does not explain the reasons for exit, state how many participants posted Month 6 satisfaction scores, or describe whether missing observations were handled through any particular method. The stated enrollment of 104 should not be treated as the number analyzed for the primary endpoint.
With a single group and no comparator, any observed satisfaction score would be descriptive of assessments recorded in this study. It would not, on its own, estimate how satisfaction or other outcomes would differ under another treatment or in the absence of the device. Other factors connected with surgery, participant selection, clinical practice, and assessment could also contribute to observed outcomes; the registry does not report analyses that address such factors.
In general, a confidence interval expresses uncertainty around an estimate, with its width reflecting both the amount of information and the variability in the data under the statistical method used. No confidence interval for the primary endpoint is reported, so the precision of any satisfaction estimate cannot be judged. A p-value is also not reported. Since there is neither a posted primary estimate nor a reported comparison, a statistical significance claim would not be supported by this record.
The registry includes serious and other adverse-event figures for the device group. These counts and listed serious-event terms describe reported safety information, but do not provide a controlled comparison of risks. The record does not report a comparator group, event timing, participant-level detail, or an analysis that would establish whether events were caused by the device or procedure.
In short, the record establishes the study’s design, endpoint definition, follow-up time, and selected safety figures. It does not present the primary outcome result or inferential analyses. Conclusions about the observed mean, variability, precision, comparative effect, or statistical significance are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies the primary outcome as a continuous measure summarized by a mean and standard deviation. It does not report a numerical mean, standard deviation, confidence interval, or analysis. The explanations below describe general statistical concepts relevant to that endpoint; they are not claims about analyses performed in this study.
What does a mean score represent?
In general, a mean is the arithmetic average of observed scores. For an investigator satisfaction scale, it would describe the central score among the observations included in the calculation. A mean can be easy to interpret when the score distribution is reasonably summarized by its center, but it can conceal variation across participants. For example, a similar mean can arise from different patterns of individual scores. The registry record does not report a score distribution or other summaries that would show such patterns.
What does the standard deviation add?
In general, the standard deviation describes the spread of observations around their mean. A small standard deviation indicates scores are relatively clustered around the mean; a larger one indicates more dispersion. It describes participant-to-participant variation, not the uncertainty of the mean itself. The standard deviation for this endpoint is not reported in the registry record, so the variation in investigators’ scores cannot be assessed.
How is uncertainty in an estimate assessed?
In general, a confidence interval gives a range of values compatible with the data and statistical method, and conveys uncertainty around an estimate. It is not a guarantee that the true value lies within that interval. Its interpretation depends on the method, assumptions, and information available. No confidence interval is reported for the primary measure, and the record does not include the underlying scores needed to review or reproduce one. The precision of the endpoint estimate is therefore not available.
What can a single-group design estimate?
A single-group design can describe outcomes observed among people in that group. It lacks a concurrent comparison group for estimating how outcomes differ under an alternative. In general, a change or score observed after an intervention may reflect several influences, including the clinical context and how participants were selected or assessed. Without a control comparison, those influences cannot be isolated by a simple between-group contrast. The registry lists allocation as NA and describes a single-group model, so comparative efficacy is not an estimand reported by the design.
What is the role of planning calculations?
In general, a sample-size planning illustration asks how much information a future comparison might need under stated assumptions about the target effect, significance level, allocation, and statistical model. The listed assumptions 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. Those are illustration assumptions, not evidence that this single-group study was designed with two arms or used that analysis plan. The registry does not report a sample-size justification or say that these assumptions were part of the study protocol. Planning sample sizes are not observed power and do not establish the precision of this study’s endpoint.
Why does over-dispersion matter in some analyses?
In general, over-dispersion occurs when observed variation in count data is greater than a statistical model expects. If ignored, uncertainty estimates from some count-data models can be too small. This concept is relevant to certain analyses of event counts, not a reason to reinterpret the continuous satisfaction endpoint as a count outcome. The registry record does not report a model for the primary endpoint or an over-dispersion assessment.
The analysis count is recorded as 0. No inferential procedure, adjustment method, covariate model, or handling of missing values is reported in the registry record. As a result, statistical methods can be explained in general, but no claim about a performed test, model, or adjusted result is warranted.
10. Confidence Intervals for Each Arm
No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| SeriScaffold® Surgical Scaffold | 88 | 8.800 | 1.500 | 8.482 to 9.118 |
R code and output
arm <- c("SeriScaffold® Surgical Scaffold")
n <- c(88)
m <- c(8.8)
sp <- c(1.5)
sd <- sp # posted standard deviations
for (i in seq_along(n)) {
se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM SeriScaffold® Surgical Scaffold 88 8.800 1.500 8.482 9.11811. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures, including investigator satisfaction, investigator assessment of ease of use, breast anatomy measurements, and subject satisfaction with breasts. The primary endpoint is investigator satisfaction at Month 6. The record’s analysis count is 0 and does not report outcome estimates or tests. It does not describe a hierarchy of hypotheses, a multiplicity adjustment, or a rule for interpreting multiple outcomes. Those details are not reported in the registry record.
In general, testing several outcomes can increase the chance of at least one apparently unusual result if each is interpreted separately. A prespecified outcome hierarchy or multiplicity method can help control that issue. Because no analysis results or analysis plan are reported, the effect of multiplicity handling cannot be assessed. It should not be assumed that any particular correction was used or omitted in the study itself.
The primary endpoint population is defined as participants with a Month 6 visit. The registry notes that 12 subjects exited before Month 6, but does not report the reasons for exit, the number with a recorded Month 6 endpoint, or how missing data were handled. It also does not state whether analyses used all enrolled participants, only participants with available observations, or another population definition. The enrollment figure does not identify the primary endpoint analysis population.
In general, missing data can affect an estimate if the people without measurements differ in relevant ways from those with measurements. The pattern and reasons for missingness matter, as do assumptions made by any statistical method. No missing-data assumptions, imputation procedure, sensitivity analysis, or analysis population beyond the stated Month 6 visit definition is reported in the registry record. The potential impact of missing endpoint values therefore cannot be evaluated.
12. 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 |
|---|---|---|---|
| SeriScaffold® Surgical Scaffold | 53 | 100 | 53.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| SeriScaffold® Surgical Scaffold | 92 of 100 |
Most frequent serious adverse event terms
| Event term | Organ system | SeriScaffold® Surgical Scaffold |
|---|---|---|
| Skin necrosis | Skin and subcutaneous tissue disorders | 6 of 100 |
| Device extrusion | General disorders | 5 of 100 |
| Pyrexia | General disorders | 3 of 100 |
| Seroma | Injury, poisoning and procedural complications | 3 of 100 |
| Physical examination abnormal | Investigations | 3 of 100 |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3 of 100 |
| Haematoma | Vascular disorders | 3 of 100 |
| Neutropenia | Blood and lymphatic system disorders | 2 of 100 |
| Capsular contracture associated with breast implant | General disorders | 2 of 100 |
| Mastitis | Infections and infestations | 2 of 100 |
Most frequent non-serious adverse event terms
| Event term | Organ system | SeriScaffold® Surgical Scaffold |
|---|---|---|
| Seroma | Injury, poisoning and procedural complications | 30 of 100 |
| Skin necrosis | Skin and subcutaneous tissue disorders | 21 of 100 |
| Erythema | Skin and subcutaneous tissue disorders | 18 of 100 |
| Nasopharyngitis | Infections and infestations | 14 of 100 |
| Breast pain | Reproductive system and breast disorders | 14 of 100 |
| Headache | Nervous system disorders | 12 of 100 |
| Device extrusion | General disorders | 9 of 100 |
| Pyrexia | General disorders | 9 of 100 |
| Wound dehiscence | Injury, poisoning and procedural complications | 9 of 100 |
| Physical examination abnormal | Investigations | 8 of 100 |
Serious events with the highest arm-level rate: skin necrosis (6.0%), device extrusion (5.0%), pyrexia (3.0%), seroma (3.0%), physical examination abnormal (3.0%).
The registry lists the SeriScaffold® Surgical Scaffold group with 100 participants at risk for serious adverse events and 53 affected. It separately lists 100 at risk for other adverse events and 92 affected. These are the posted figures for the categories as recorded; they are not results from a comparison with a control group.
The registry also lists serious adverse-event terms with percentages: Skin necrosis, 6.0%; Device extrusion, 5.0%; Pyrexia, 3.0%; Seroma, 3.0%; Physical examination abnormal, 3.0%; and Metastases to lymph nodes, 3.0%. These entries identify terms and reported percentages, but the record does not provide further detail about timing, duration, severity beyond the serious-event classification, recurrence, or individual participants. It also does not report deaths; the deaths field is null.
In general, an adverse event recorded after treatment is not automatically evidence that the treatment caused it. Attribution, timing, background event rates, and a suitable comparison are relevant to causal interpretation. With a single group and no control comparison, the listed figures describe reported events in the group and should not be read as comparative risk estimates or as proof of causation.
13. What the Result Does, and Does Not, Mean
The registry record establishes that the study was a completed post-market evaluation of SeriScaffold® in breast reconstruction surgery, with a single-group design. It identifies investigator satisfaction at Month 6 as the primary endpoint and describes the scale’s anchors and summary measure. It also records selected serious and other adverse-event figures and several serious-event terms.
Those design and outcome definitions help clarify what the study set out to describe. The primary question concerns investigators’ satisfaction after stage I surgery or implantation, not a randomized comparison of the device with another treatment. The secondary outcomes broaden the types of experience recorded, including ease of use, breast anatomy, and subject satisfaction.
The registry record does not report the primary endpoint’s mean or standard deviation, nor does it give a confidence interval or analysis result. As a result, it does not establish the observed satisfaction score or its precision. It also does not report inferential analyses for the secondary outcomes. No conclusion about statistical significance can be drawn from the absence of posted analyses.
The safety figures should likewise be understood as descriptive records in a single group. Without a comparator, they do not establish how event frequencies would differ under another treatment, and the listed terms do not by themselves demonstrate causation. The null deaths entry should not be expanded into a claim about the full details of mortality monitoring or reporting.
More broadly, this record does not show whether the device performed better or worse than an alternative, nor does it permit a causal estimate of its effect. It documents a post-market study design and selected outcome and safety information. Any interpretation should distinguish that descriptive information from comparative evidence, which is not reported in the registry record.
14. Why This Trial Matters Statistically
This study is statistically useful to examine because its design and its primary question need to be read together. Investigator satisfaction on a defined scale can describe an aspect of device use, but a single-group design does not provide a concurrent control comparison. The design therefore shapes the kinds of conclusions the data could support even if endpoint results were reported.
The endpoint is explicitly defined by its assessment time, scale anchors, and summary measure. That is important for interpreting what a score would mean: it is investigators’ satisfaction at Month 6, summarized as a mean with standard deviation, rather than a direct measure of anatomy or subject satisfaction. The registry also identifies related secondary measures, making clear that the study considered more than one dimension of experience.
The record highlights a further statistical issue: the stated primary population is participants with a Month 6 visit, while 12 subjects exited before that visit. Without the number assessed or an account of missing-data handling, readers cannot judge the endpoint’s completeness or assess the possible influence of missingness. Clear reporting of analysis populations and missing data is essential for understanding a result’s reliability.
Most importantly, the registry does not report the primary result or analysis. This limits statistical interpretation more fundamentally than uncertainty about a particular test: there is no posted estimate to evaluate for magnitude or precision. The safety figures offer descriptive information, but do not replace a controlled comparison. Separating what the study design can address from what the registry actually reports is central to a sound reading of this record.
15. 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 for interpreting outcomes is that the registry record does not report the primary endpoint result. It specifies the Month 6 satisfaction scale and summary approach, but gives no mean, standard deviation, confidence interval, or analysis result. The record therefore does not permit assessment of the observed endpoint level or its precision.
The single-group design provides no control arm for a like-for-like comparison. The allocation field is NA, masking is NONE, and the model is single-group. Consequently, the record does not support a comparative treatment estimate or a causal contrast against another approach.
The primary population is defined by having a Month 6 visit, and the record states that 12 subjects exited before Month 6. It does not describe reasons for exit, report the number assessed at Month 6, explain missing-data handling, or specify the primary analysis population beyond the visit-based definition. These omissions limit evaluation of completeness and potential selection effects.
The registry lists five outcome measures but reports 0 analyses. It does not state whether outcomes were prespecified in an analysis hierarchy, how multiple outcomes were handled, or whether any covariate adjustment or sensitivity analysis was used. These elements are not reported in the registry record.
Safety interpretation is also limited by the absence of a comparison group and by limited event detail. The record does not provide event timing, attribution, or participant-level descriptions. Other study details, including eligibility criteria, recruitment methods, site information, and the statistical analysis plan, are not reported in the registry record. These limitations concern what can be interpreted from the registry entry; they do not establish what may or may not have been conducted outside the record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe — NCT01389232.
- Registry record last updated 2021-06-21; status last verified 2021-05.
- Results first posted 2021-06-21.
- 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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19. Record Summary
NCT01389232 is a completed post-market, single-group study of the SeriScaffold® Surgical Scaffold for breast reconstruction surgery in Europe. The study began in 2011-06 and reached primary completion in 2013-08. Enrollment is recorded as 104, and Sofregen Medical, Inc. is listed as sponsor.
The primary endpoint is investigator satisfaction at Month 6, measured on an 11-point scale and summarized by a mean and standard deviation. The record notes that 12 subjects exited before Month 6. It lists five outcome measures and an analysis count of 0, but does not report a numerical primary endpoint result or statistical analysis.
Safety entries include serious and other adverse-event figures for the study group and a list of serious-event terms with percentages. As a single-group record without a comparator, these entries are descriptive and do not provide a comparative risk estimate.