European New Texture Implant Clinical Experience With Shaped Breast Implants

Study Identifier
ENTICE-002
CT.gov Identifier
NCT01639755
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Breast Augmentation
    • Study Drug
    N/A
    Phase
    Phase 4
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Klinik 34
    Göteburg, Sweden, 41124
    Status
    Not applicable
    Location
    Akademikliniken 10
    Stockholm, Sweden, 11542
    Status
    Not applicable