Phase 4
Completed N=19
European New Texture Implant Clinical Experience With Shaped Breast Implants
Breast Augmentation
Source: ClinicalTrials.gov NCT01639755 ↗
Enrolled (actual)
19
Serious AEs
10.5%
Results posted
Jul 2015
Primary outcomePrimary: Investigator Overall Satisfaction With the Device Using a 5-Point Scale — 4.6 score on a scale
Summary
The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Overall Satisfaction With the Device Using a 5-Point Scale |
4.6 | — |
| SECONDARY Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire |
87.1 | — |
| SECONDARY Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue |
2.5 | — |
| SECONDARY Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale |
88.9; 11.1; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Local Complications |
100.0; 15.8 | — |
Eligibility Criteria
Inclusion Criteria
- Be willing to undergo bilateral breast augmentation with subglandular, submuscular, or biplanar placement of the breast implants by inframammary approach only
- Be a candidate for the device styles and sizes available in the study
Exclusion Criteria
- Have tuberous breasts, congenital anomalies of the breast (e.g., Poland's Syndrome), or grade 3 ptosis
- Have undergone any previous breast surgery
- Have tissue covering determined inadequate or unsuitable by the surgeon
Data sourced from ClinicalTrials.gov (NCT01639755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.