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 SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery (NCT02030938), a na na study. The primary outcome is Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02030938 |
| Phase | NA |
| Condition | Subjects Requiring Revision Breast Augmentation Surgery |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 34 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sofregen Medical, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Subjects requiring revision breast augmentation surgery for increased nipple to inframammary fold distance. The registry lists enrollment of 34.
Intervention
SERI® Surgical Scaffold, a device described as a knitted, multifilament, bioengineered silk mesh, implanted in breasts undergoing the surgery.
Comparator
No concurrent comparator is recorded. The trial is listed as single-group, with allocation recorded as NA and masking recorded as none.
Primary question
At 12 months, how many implanted breasts require reoperation for recurrence of the initial cause of increased nipple to inframammary fold distance?
The registry frames the evaluation around clinical performance of the scaffold when used for soft tissue support during revision augmentation surgery. The primary outcome is specific to reoperation for the presenting condition; it is not a general measure of every reason a breast might undergo another procedure. Reoperation for any cause is separately listed as a secondary outcome.
The question is descriptive rather than a direct comparison of the scaffold with another treatment. Without a concurrent control group, the record cannot establish how the observed course would compare with an alternative approach under otherwise similar conditions. The endpoint can describe the frequency of the specified reoperation among implanted breasts during the stated follow-up, but an outcome rate alone cannot isolate the scaffold's contribution from other factors associated with surgery, patient characteristics, or follow-up.
3. Trial Design
The registry identifies NCT02030938 as an evaluation of SERI® Surgical Scaffold for soft tissue support in revision augmentation surgery. The condition is listed as subjects requiring revision breast augmentation surgery. The brief summary describes the intended setting as surgery for increased nipple to inframammary fold distance. The intervention is classified as a device, and the study model is single-group.
Enrollment is listed as 34. That enrollment figure should not be assumed to be interchangeable with the number of implanted breasts used as the unit for some outcomes. The primary outcome is expressed per implanted breast, while one listed secondary outcome, the difference in BREAST-Q scores, is expressed per patient. These are different analysis units, and the registry excerpt does not explain how they are related for each outcome.
Allocation is recorded as NA, and masking is recorded as none. No randomized allocation or concurrent control arm is described. The record lists the study as completed, with a start date of 2013-12 and a primary completion date of 2015-12. Those administrative dates do not themselves provide the endpoint findings or explain how participants were followed or analyzed.
The registry lists reoperation rate for the presenting condition at 12 months as the primary outcome. Secondary outcomes include reoperation for any cause, adverse-event incidence at 30 days and 12 months, change in mammometry from baseline to 12 months, and change in BREAST-Q scores across four scales from baseline to 12 months. The registry record does not report a statistical analysis for these outcomes in the information.
The intervention description calls the scaffold a sterile, single-use mesh, and describes it as bioresorbable. Those are descriptions of the device, not trial findings. Details such as the operative technique, eligibility criteria beyond the stated condition, follow-up procedures, and treatment of missing observations are not reported in the registry record.
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 | SERI® Surgical Scaffold Implanted Breasts |
|---|---|
| STARTED | 34 |
| COMPLETED | 29 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | SERI® Surgical Scaffold Implanted Breasts |
|---|---|
| Lost to Follow-up | 4 |
| Withdrawal by Subject | 1 |
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 | SERI® Surgical Scaffold Implanted Breasts |
|---|---|---|
| Participants analysed | 34 | |
| Age, Continuous | years | 44.4 (SD 13.37) |
| Sex/Gender, Customized: Sex – Female - Child-bearing Potential | Participants | 22 |
| Sex/Gender, Customized: Sex – Female - Non Child-bearing Potential | Participants | 12 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 30 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months., measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Implanted breasts |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the reoperation rate per implanted breast for the presenting condition at 12 months. The presenting condition is defined as recurrence of the initial cause of increased nipple to inframammary fold distance. The registry describes reporting the number of implanted breasts requiring that reoperation relative to the overall number of units analyzed, with a 95% confidence interval.
This endpoint focuses on a clinically recognizable event: another operation prompted by recurrence of the problem that led to the revision procedure. It is narrower than reoperation for any cause, which the registry lists separately as a secondary outcome. A reoperation for a different reason would not necessarily meet the primary endpoint definition. Keeping these outcomes distinct helps clarify what event is being counted and what question the rate addresses.
The unit is the implanted breast, not the patient. This matters because the endpoint concerns outcomes in treated breasts, while other listed measures use the patient as the unit. The registry record does not report the observed primary count, denominator analyzed, confidence interval, or a statistical analysis. Accordingly, the endpoint definition can be described, but its estimated rate and precision cannot be stated from the registry record.
In general, a confidence interval expresses uncertainty around an estimated quantity. Its width depends on the information available and the variability in the data. Without the estimate and interval, the precision of the primary endpoint cannot be assessed. Nor can the registry description alone establish whether any reoperation reflects recurrence attributable to the original condition, the procedure, the device, or other causes beyond the endpoint's stated definition.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record gives a clear description of the intended primary outcome, but it does not provide the primary result. In particular, the posted information does not state the number of implanted breasts that required reoperation for recurrence of the presenting condition, the number analyzed, or the corresponding 95% confidence interval. The primary endpoint therefore cannot be interpreted as an observed rate from this registry record.
The study is listed as completed, and enrollment is 34. Completion and enrollment are design and administrative details; they are not substitutes for outcome data. They do not indicate how many outcome events occurred, whether all enrolled participants contributed to the analysis, or how precise an estimated rate might be. The registry record does not report those details.
The single-group design also shapes what any eventual rate could mean. A single-group outcome can describe what was observed among the treated group, but without a concurrent comparator it cannot directly quantify a difference from another treatment or from no scaffold. It also cannot by itself separate the possible contribution of the scaffold from the effects of surgery, patient characteristics, or other influences. This is a limitation of the comparison structure, not a claim about the device's effect.
The listed secondary outcomes broaden the planned assessment. They include reoperation for any cause at 12 months, adverse-event incidence at 30 days and 12 months, mammometry change from baseline to 12 months, and BREAST-Q score differences from baseline to 12 months. The registry record does not supply numerical findings for those measures or report their analyses. Their inclusion in the outcome list should not be read as evidence that a particular result occurred.
Safety information is recorded separately: the registry lists serious and other adverse-event counts for the implanted-breast group and identifies a serious-event term. Those figures should be read as descriptive registry entries, not as a comparative estimate of risk. The single-group design provides no concurrent control rate, and the record excerpt does not explain event definitions, attribution procedures, or how repeated events were handled.
Planning calculations, when presented as illustrations, answer a different question from the trial's results. The stated assumptions describe a hypothetical two-arm sample-size framework based on an observed effect; they do not describe the single-group trial's own design, and they are not observed power. Since numerical planning outputs are not reported in the registry record, no sample-size conclusion can be drawn from these registry entries.
Overall, the record establishes the study question, design, outcome definitions, and selected safety counts. It does not establish the observed primary outcome or its precision. Interpretation should therefore remain at the level of what was planned and what safety entries are listed, without drawing a conclusion about treatment benefit or lack of benefit.
9. Statistical Methods Explained
The registry identifies the primary outcome as a rate per implanted breast and specifies a 95% confidence interval. Understanding that description requires distinguishing the outcome unit, the event definition, and the uncertainty around an estimate. The event is reoperation for recurrence of the initial cause of increased nipple to inframammary fold distance; the unit is the implanted breast. The registry record does not report the actual estimate, the analyzed denominator, or the interval, so the statistical interpretation of the observed rate is unavailable.
What does a confidence interval communicate?
In general, a confidence interval is a range of values compatible with the data under a specified statistical procedure. It communicates uncertainty around an estimate rather than guaranteeing that the true value lies within a particular range. For a rate, the interval's width reflects how much information is available and the statistical method used. The record specifies a 95% confidence interval for the primary outcome, but it does not give the interval or enough reported outcome information to evaluate its width.
A confidence interval is not a test of whether the intervention works. It describes estimation uncertainty, and interpretation also depends on study design, outcome definition, and the presence or absence of a comparator. Here, the single-group design means the primary rate would describe observed reoperations in the treated group; it would not by itself estimate a contrast against another treatment.
Why does the analysis unit matter?
The primary outcome is measured per implanted breast. The registry also lists a BREAST-Q outcome per patient. These units are not interchangeable: a breast-level event and a patient-level score summarize different kinds of information. The registry record does not explain how any within-patient relationship between implanted breasts was handled in the analysis. This matters in general because observations from the same person may be related, and methods that treat related observations as independent can give misleading uncertainty estimates.
The enrollment figure is 34, while the primary endpoint is defined per implanted breast. The enrollment figure should not be treated as the primary endpoint's analyzed denominator. The registry record does not state the number of breasts analyzed for the primary outcome, or whether all enrolled participants contributed observations at each follow-up time.
What does the single-group structure allow?
A single-group study can describe outcomes observed after the intervention. Without a concurrent control group, it cannot directly estimate a between-group treatment difference. A rate observed in the group may be influenced by features of the participants, the revision operation, follow-up, and other factors as well as the intervention. This general design limitation applies regardless of whether an outcome is favorable or unfavorable.
Allocation is listed as NA, and masking as none. The record therefore does not describe randomized allocation or masking. No specific rationale for those design choices, or details about outcome assessment procedures, are reported in the registry record. The absence of masking may matter for outcomes involving judgment or reporting, but the registry entries do not establish whether or how this affected any assessment.
How should the planning assumptions be read?
The stated sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. This is not the design recorded for the study, which is listed as single-group. The illustration is not an observed-power calculation and should not be interpreted as a result from the enrolled group. The registry record does not report the trial's own sample-size justification or design calculations.
The assumptions also distinguish planning conventions by outcome type: time-to-event illustrations use a total number of events, while other illustrations use participants per arm. These are general planning quantities, not observed trial outcomes. Sample-size illustrations at fractions of an observed effect describe hypothetical targets; they do not show that a trial actually observed an effect of that size, nor that it had a particular probability of detecting it.
What statistical details are unavailable?
The registry record reports no analyses in the registry record described. It does not report a model for the primary outcome, covariate adjustment, handling of repeated observations, missing-data methods, interim analyses, or a statistical analysis plan. It also does not report whether the confidence interval was calculated using a particular method. Without those details and the numerical endpoint result, the precision and robustness of the primary estimate cannot be evaluated.
In general, over-dispersion occurs when variation in count data exceeds what a chosen model expects. A model that does not account for over-dispersion may understate uncertainty. The registry information does not indicate that count modeling or an over-dispersion adjustment was used in this study; this general concept should not be mistaken for a method reported for the trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome and several secondary outcomes, but the information described does not report a multiplicity strategy. Multiplicity refers to the increased chance of at least one apparently notable result when multiple outcomes or statistical tests are considered. In general, investigators may prespecify how to control or interpret this issue, but no such approach is reported in the registry record. The outcome list alone does not establish whether any adjustment was planned or used.
The primary endpoint is reoperation for recurrence of the presenting condition at 12 months. Secondary outcomes include reoperation for any cause at 12 months, adverse-event incidence at 30 days and 12 months, mammometry change from baseline to 12 months, and differences in BREAST-Q scores across four scales from baseline to 12 months. The registry record does not provide results or analyses for these outcomes in the information described, so there are no reported comparisons or statistical significance findings to interpret.
Missing-data handling and analysis populations are also not reported in the registry record. The available description does not say how missing follow-up information was handled, which observations were included in each analysis, or whether any participants or implanted breasts were excluded from an outcome analysis. It also does not state whether analyses followed an intention-to-treat, per-protocol, or other population definition. These details matter because the analyzed group and missing observations can affect both the estimated outcome and its uncertainty.
In general, missing outcomes can create bias if the likelihood of missingness is related to the outcome or participant characteristics. The direction and extent of any such bias cannot be inferred without information about missingness and the analysis approach. Since the record does not report these details or the primary analysis itself, neither the effect of missing data nor the handling of multiplicity can be assessed.
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 |
|---|---|---|---|
| SERI® Surgical Scaffold Implanted Breasts | 1 | 34 | 2.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| SERI® Surgical Scaffold Implanted Breasts | 0 of 34 |
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 |
|---|---|
| SERI® Surgical Scaffold Implanted Breasts | 13 of 34 |
Most frequent serious adverse event terms
| Event term | Organ system | SERI® Surgical Scaffold Implanted Breasts |
|---|---|---|
| Breast complication associated with device | General disorders | 1 of 34 |
Most frequent non-serious adverse event terms
| Event term | Organ system | SERI® Surgical Scaffold Implanted Breasts |
|---|---|---|
| Breast pain | Reproductive system and breast disorders | 3 of 34 |
| Breast mass | Reproductive system and breast disorders | 2 of 34 |
| Breast haematoma | Reproductive system and breast disorders | 1 of 34 |
| Breast swelling | Reproductive system and breast disorders | 1 of 34 |
| Procedural pain | Injury, poisoning and procedural complications | 1 of 34 |
| Suture rupture | Injury, poisoning and procedural complications | 1 of 34 |
| Physical breast examination abnormal | Investigations | 1 of 34 |
| Physical examination abnormal | Investigations | 1 of 34 |
| Breast complication associated with device | General disorders | 1 of 34 |
| Incision site cellulitis | Infections and infestations | 1 of 34 |
Serious events with the highest arm-level rate: breast complication associated with device (2.9%).
The registry lists safety counts for the group titled SERI® Surgical Scaffold Implanted Breasts. It records 34 implanted breasts at risk for serious adverse events and 1 affected, and 34 at risk for other adverse events and 13 affected. Deaths are recorded as 0. The registry also identifies “Breast complication associated with device” as a top serious-event term, with 2.9% listed.
These entries are descriptive safety information. The registry record does not explain the event definitions, severity criteria, attribution process, or whether the counts represent people, breasts, or individual event episodes beyond the group and unit labels shown. The counts should therefore be reported as registry entries rather than interpreted as a comparative risk estimate.
There is no concurrent control group in this single-group study, so these figures cannot establish how event occurrence compares with another treatment or with no scaffold. The record also does not provide a detailed account of event timing, duration, resolution, or the relationship between the listed serious-event term and the overall serious-event count. These safety entries do not substitute for the missing primary reoperation result, and they do not by themselves establish causation or treatment effect.
12. What the Result Does, and Does Not, Mean
The registry record establishes that SERI® Surgical Scaffold was evaluated in a single-group study of revision augmentation surgery, with reoperation for recurrence of the presenting condition at 12 months designated as the primary endpoint. It also identifies secondary outcomes and includes selected adverse-event counts. These registry entries describe the study's scope and some recorded safety information.
The record does not report the observed primary reoperation count, the number analyzed, or the 95% confidence interval. It also does not report numerical results for the listed secondary outcomes. Consequently, the posted information does not support a conclusion about the frequency or precision of the primary outcome. A completed study status does not fill in those missing findings.
Even if a primary rate were available, a single-group study would describe outcomes within the treated group rather than estimate a direct contrast with a concurrent alternative. Without such a comparison, the rate alone could not determine what would have happened under another approach, or separate the possible contribution of the scaffold from other influences. This is a limitation on causal interpretation, not a claim that any particular outcome was favorable or unfavorable.
The safety entries should be interpreted with similar care. They describe counts recorded for the implanted-breast group, including a listed serious-event term, but do not provide a controlled comparison. Nor does the record excerpt provide enough detail to evaluate event attribution or the handling of repeated events.
Thus, the appropriate conclusion is bounded: the registry describes the clinical question, design, endpoint definitions, and selected safety entries, but the primary efficacy result and several analysis details are not reported in the registry record. No conclusion about treatment benefit, lack of benefit, or comparative safety follows from the information recorded.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its primary endpoint is defined per implanted breast, whereas enrollment is reported as a participant count and one secondary measure is defined per patient. Keeping those units distinct is essential when interpreting denominators, event rates, and uncertainty. The registry record does not provide the analyzed denominator for the primary endpoint, so enrollment alone cannot be used to reconstruct its rate.
The design also clarifies the difference between describing an outcome and estimating a treatment contrast. A single-group study can characterize outcomes in the group receiving the device, but it does not have a concurrent control group for a direct comparison. This distinction is fundamental: an observed event rate and a comparative treatment effect answer different statistical questions.
The endpoint definition is another important feature. Reoperation for recurrence of the presenting condition is narrower than reoperation for any cause. Treating those as the same outcome would blur the clinical meaning of the measure. The registry lists them separately, making clear that the reason for reoperation matters to the question being asked.
Finally, the record illustrates why registration details and outcome results must be distinguished. It identifies the planned primary outcome, follow-up time, secondary outcome domains, and safety entries, but does not report the primary result or its confidence interval. A completed status and detailed endpoint wording do not establish an observed finding. Statistical interpretation depends on both a clearly defined question and reported data with enough detail to assess their precision and limitations.
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.
Important study details are not reported in the registry record. The information described does not give the eligibility criteria in detail, the operative protocol, the follow-up schedule beyond listed outcome time points, or the procedures used to assess outcomes. It also does not state how the study handled deviations from treatment or whether participants received other interventions that might affect outcomes.
The primary endpoint is expressed per implanted breast, but the analyzed denominator is not reported. The record also does not explain how related observations from the same patient were handled. Because the number enrolled is not necessarily the same as the number of outcome units analyzed, the enrollment figure cannot establish the endpoint denominator or the completeness of follow-up.
Allocation is recorded as NA, masking as none, and the model as single-group. There is no concurrent comparator described. This limits direct comparative interpretation and leaves the outcome subject to influences that cannot be separated using a treatment contrast. The registry record does not report the rationale for this design or a protocol-level account of its limitations.
Outcome reporting is incomplete in the information described: numerical primary and secondary results, confidence limits, and statistical analyses are not reported. The record also does not report missing-data procedures, analysis populations, multiplicity handling, interim analyses, or the trial's own sample-size justification. Without those details, readers cannot assess the precision of the endpoint estimate, the robustness of analyses, or how much missing information might affect results.
The safety entries lack additional context on event definitions, attribution, timing, and handling of repeated events. They should be read as registry counts, not as evidence of causation or as comparative safety estimates. These limitations restrict interpretation to the study description and the safety information actually listed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery — NCT02030938.
- Registry record last updated 2021-12-28; status last verified 2021-11.
- Results first posted 2021-12-28.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02030938 is listed as a completed, single-group evaluation of SERI® Surgical Scaffold for soft tissue support in revision augmentation surgery. Enrollment is 34; the record lists a start date of 2013-12 and a primary completion date of 2015-12. Allocation is NA, and masking is none.
The primary endpoint is reoperation per implanted breast for recurrence of the presenting condition at 12 months, reported as a number and with a 95% confidence interval. The registry record does not report the primary result, analyzed denominator, or interval. Listed secondary outcomes include reoperation for any cause, adverse-event incidence, mammometry change, and BREAST-Q score changes.
Safety entries list 1 affected among 34 at risk for serious adverse events, 13 affected among 34 at risk for other adverse events, and 0 deaths. “Breast complication associated with device” is listed as a top serious-event term at 2.9%. These are descriptive registry entries; the single-group design does not provide a concurrent comparison.