NL-OMON48726撤回不适用
A prospective, single-arm, open-label, multicenter clinical investigation to assess the safety and performance of SILKline breast implants in healthy female subjects - POSIS
Polytech Health&Aesthetics GmbH0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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.
研究者
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