NCT01639742

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2013

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

July 29, 2015

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2017

Completed
Last Updated

November 30, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

July 11, 2012

Results QC Date

July 2, 2015

Last Update Submit

October 26, 2017

Conditions

Breast Augmentation

Outcome Measures

Primary Outcomes (1)

  • Investigator Overall Satisfaction With the Device Using a 5-Point Scale

    The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.

    3 months

Secondary Outcomes (4)

  • Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire

    6 months

  • Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue

    6 months

  • Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale

    Interim analysis: 12 months

  • Percentage of Participants With Local Complications

    Interim analysis: 12 months

Study Arms (1)

All Participants

EXPERIMENTAL

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

Device: New texture round breast implants

Interventions

New texture round breast implantsDEVICE

Breast implant surgery

All Participants

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Praxisklinik Siepe Friedrichstraße 57

Bonn, 53111, Germany

Location

Malteser Krankenhaus

Bonn, 53123, Germany

Location

Akademikliniken 10

Stockholm, 11542, Sweden

Location

Dolan Park Hospital

Birmingham, B60 1LY, United Kingdom

Location

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Per Heden

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 13, 2012

Study Start

June 18, 2012

Primary Completion

January 30, 2013

Study Completion

October 12, 2017

Last Updated

November 30, 2017

Results First Posted

July 29, 2015

Record last verified: 2017-10

Locations

DE(2)GB(1)SE(1)