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European New Texture Implant Clinical Experience With Round Breast Implants

NCT ID: NCT01639742

Last Updated: 2017-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-18

Study Completion Date

2017-10-12

Brief Summary

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

Detailed Description

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Conditions

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Breast Augmentation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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All Participants

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

Group Type EXPERIMENTAL

New texture round breast implants

Intervention Type DEVICE

Breast implant surgery

Interventions

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New texture round breast implants

Breast implant surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per Heden

Role: STUDY_DIRECTOR

Allergan

Locations

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Praxisklinik Siepe Friedrichstraße 57

Bonn, , Germany

Site Status

Malteser Krankenhaus

Bonn, , Germany

Site Status

Akademikliniken 10

Stockholm, , Sweden

Site Status

Dolan Park Hospital

Birmingham, , United Kingdom

Site Status

Countries

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Italy Germany Sweden United Kingdom

Other Identifiers

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ENTICE-001

Identifier Type: -

Identifier Source: org_study_id