NCT00691327已完成不适用
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84,329
- 试验地点
- 1
- 主要终点
- Local Complications
研究概览
简要总结
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate.
- •Females seeking revision augmentation or revision reconstruction, where problems exist
- •Have any of the following conditions or situations present:
- •Post mastectomy surgical removal of the breast for cancer or other disease;
- •Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity;
- •Severe ptosis requiring reconstruction;
- •Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity.
- •Adequate tissue available to cover implants.
- •Saline-filled implants are not an appropriate choice.
排除标准
- •Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
- •Existing carcinoma of the breast, without mastectomy.
- •Abscess of infection in the body at the time of enrollment.
- •Pregnant or nursing.
- •Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
- •Show tissue characteristics which are clinically incompatible with mammaplasty.
- •Have, or under treatment for any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk.
- •Are not willing to undergo further surgery for revision, if medically required.
- •Diagnosis of lupus or scleroderma.
结局指标
主要结局
Local Complications
时间窗: 5 years
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
次要结局
- Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale(5 years)
研究者
研究点 (1)
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