European New Texture Implant Clinical Experience With Shaped Breast Implants
1 other identifier
interventional
19
1 country
2
Brief Summary
The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2012
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2012
CompletedFirst Submitted
Initial submission to the registry
July 11, 2012
CompletedFirst Posted
Study publicly available on registry
July 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2013
CompletedResults Posted
Study results publicly available
July 29, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2017
CompletedNovember 30, 2017
October 1, 2017
8 months
July 11, 2012
July 2, 2015
October 26, 2017
Conditions
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
EXPERIMENTALAl participants who had new texture shaped breast implants surgically implanted.
Interventions
Eligibility Criteria
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
- Allerganlead
Study Sites (2)
Klinik 34
Göteburg, 41124, Sweden
Akademikliniken 10
Stockholm, 11542, Sweden
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Per Heden
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- 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 16, 2017
Last Updated
November 30, 2017
Results First Posted
July 29, 2015
Record last verified: 2017-10