European New Texture Implant Clinical Experience With Round Breast Implants

Allergan

Status: Completed

Conditions: Breast Augmentation

Treatments: Device: New texture round breast implants

Study type: Interventional

Funder types: Industry

Identifiers

NCT01639742

ENTICE-001

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

All Participants

Experimental group

Description:

All participants who had new texture round breast implants surgically implanted.

Treatment:

Device: New texture round breast implants