NCT00858052已完成不适用
Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants in Women Who Are Undergoing Primary Breast Augmentation or Replacement of Existing Augmentation Implants
Ideal Implant Incorporated24 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2009年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 24
- 主要终点
- Determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants.
研究概览
简要总结
The objective of this study is to determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants.
详细描述
For complete information about the clinical trial, see link in the reference section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Bilateral primary breast augmentation-dissatisfaction with breast size
- •Bilateral replacement augmentation-has had previous silicone saline-filled or gel-filled breast implants
排除标准
- •Diagnosis of active cancer of any type
- •Has ever been diagnosed with breast cancer
- •Has pre-malignant breast disease
- •Has tissue characteristics incompatible with an implant
- •Has unrealistic or unreasonable expectations of the procedure results
研究组 & 干预措施
breast augmentation
Experimental
breast implant
干预措施: Saline-filled breast implant [IDEAL IMPLANT (R)] (Device)
结局指标
主要结局
Determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants.
时间窗: 2 mo, 6 mo, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 yrs.
次要结局
未报告次要终点
研究者
研究点 (24)
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