Dissatisfaction with appearance of the breast aesthetic preference Dissatisfaction with appearance
Conditions
Interventions
Yes: Surgery for breast augmentation
Sponsors
Polytech Health&Aesthetics GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Female and at least 18 years of age. 2.Seeking primary breast augmentation. The size of the requested device for subject*s breast augmentation is between 240 mL and 400 mL. 3. Written informed consent after being informed of the study procedure and risks, prior to any study-related events. 4. Good general state of health (mentally and physically). Laboratory parameters and vital signs not showing any clinically significant abnormalities. 5. Able to undergo general anesthesia and subject is a suitable surgical candidate. 6. Willing and able to return to a study site for postprocedural follow-up examinations.
Exclusion criteria
Exclusion criteria: 1. Pregnancy. 2. Female subjects of childbearing capacity who are not willing to employ a highly effective contraceptive measure for the duration of the clinical study (i.e. double barrier method combined with hormonal contraceptives or intrauterine device, total abstinence). 3. Breast feeding women or less than 6 months after stopping breast feeding. 4. Breast reconstruction or augmentation history. 5. Previous silicone implants. 6. Known genetic or familial predisposition to breast cancer. 7. Known abscesses, cysts or tumors in the area of implants, advanced fibrocystic diseases. 8. Existing costal injuries 9. Clinically significant diagnosis of any severe acute or chronic illness such as oncological diseases, autoimmune diseases, wound healing disorders, diabetes mellitus. 10. Positive human immunodeficiency virus, hepatitis B or C test result. 11. Heavy burn scars or insufficient tissue covering in the prospective area of implantation. 12. Subjects not willing to refrain from recreational drugs. 13. Continuous intake of drugs acting on the central nervous system e.g. antidepressants, antiepileptics, sedatives. 14. Known or suspected allergy, intolerance or adverse reaction to antibiotics, anesthetics and/or products used during the surgery. 15. Subjects who are currently participating or who have participated in any other clinical trial within 60 days prior to enrollment and subjects who are not willing to refrain from participation in any other clinical trial during the participation in this study. 16. Subjects who are unable to comply with the Clinical Investigation Plan requirements. 17. Employees of the sponsor or subjects who are employees or relatives of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No statistical hypothesis testing will be done for the primary endpoint, incidence of uSADEs. The objective of the study is not met if at least one uSADE will be reported during the study. Subject reported outcome: Questionnaire Investigator reported outcome: Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| No statistical hypothesis testing will be done for the primary endpoint, incidence of uSADEs. The objective of the study is not met if at least one uSADE will be reported during the study. Subject reported outcome: Questionnaire Investigator reported outcome: Questionnaire | — |
Countries
Netherlands
Outcome results
None listed