Breast Augmentation Clinical Trial
Official title:
European New Texture Implant Clinical Experience With Round Breast Implants
Verified date | October 2017 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation.
Status | Completed |
Enrollment | 18 |
Est. completion date | October 12, 2017 |
Est. primary completion date | January 30, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Malteser Krankenhaus | Bonn | |
Germany | Praxisklinik Siepe Friedrichstraße 57 | Bonn | |
Sweden | Akademikliniken 10 | Stockholm | |
United Kingdom | Dolan Park Hospital | Birmingham |
Lead Sponsor | Collaborator |
---|---|
Allergan |
Germany, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire | Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale. | 6 months | |
Secondary | Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue | The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue. | 6 months | |
Secondary | Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale | The investigator evaluated capsular contracture (lining of cells formed around the device as the body's response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported. | Interim analysis: 12 months | |
Secondary | Percentage of Participants With Local Complications | The percentage of participants experiencing local complications (in the area of the implant) is reported. | Interim analysis: 12 months |
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