European New Texture Implant Clinical Experience With Shaped Breast Implants

Allergan

Status and phase: Completed; Phase 4

Conditions: Breast Augmentation

Treatments: Device: new texture shaped breast implants

Study type: Interventional

Funder types: Industry

Identifiers

NCT01639755

ENTICE-002

Details and patient eligibility

About

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

Enrollment: 19 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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19 participants in 1 patient group

All Participants

Experimental group

Description:

Al participants who had new texture shaped breast implants surgically implanted.

Treatment:

Device: new texture shaped breast implants