This trial is active, not recruiting.

Condition breast augmentation
Treatment new texture round breast implants
Sponsor Allergan
Start date June 2012
End date March 2014
Trial size 18 participants
Trial identifier NCT01639742, ENTICE-001


The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
new texture round breast implants
Breast implant surgery

Primary Outcomes

Investigator's overall satisfaction with the device will be evaluated using a 5-point scale
time frame: 3 months

Secondary Outcomes

Subject satisfaction with breasts will be measured using the BREAST-Q questionnaire
time frame: 6 months
Investigator evaluation of whether the implant is palpably distinguishable from the tissue
time frame: 6 months
Presence of capsular contracture evaluated on a 5-Point Scale
time frame: 2 years
Local complications evaluated by Four-grade Baker Scale
time frame: 2 years

Eligibility Criteria

Female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Allergan.