Phase 4
N=19
European New Texture Implant Clinical Experience With Shaped Breast Implants
Breast Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT01639755 ↗Enrolled (actual)
19
Serious AEs
10.5%
Results posted
Jul 2015
Primary outcome: Primary: Investigator Overall Satisfaction With the Device Using a 5-Point Scale — 4.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- new texture shaped breast implants (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Allergan
- Primary completion
- Jan 2013
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 | — |
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.
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.