A prospective, single-arm, open-label, multicenter clinical investigation to assess the safety and performance of SILKline breast implants in healthy female subjects
- Conditions
- Dissatisfaction with appearance of the breastaesthetic preferenceDissatisfaction with appearance
- Registration Number
- NL-OMON48726
- Lead Sponsor
- Polytech Health&Aesthetics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>No statistical hypothesis testing will be done for the primary endpoint,<br /><br>incidence of uSADEs. The objective of the study is not met if at least one<br /><br>uSADE will be reported during the study.<br /><br><br /><br>Subject reported outcome: Questionnaire<br /><br>Investigator reported outcome: Questionnaire</p><br>
- Secondary Outcome Measures
Name Time Method <p>No statistical hypothesis testing will be done for the primary endpoint,<br /><br>incidence of uSADEs. The objective of the study is not met if at least one<br /><br>uSADE will be reported during the study.<br /><br><br /><br>Subject reported outcome: Questionnaire<br /><br>Investigator reported outcome: Questionnaire</p><br>