NCT01639755已完成4 期
European New Texture Implant Clinical Experience With Shaped Breast Implants
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Investigator Overall Satisfaction With the Device Using a 5-Point Scale
研究概览
简要总结
The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Be willing to undergo bilateral breast augmentation with subglandular, submuscular, or biplanar placement of the breast implants by inframammary approach only
- •Be a candidate for the device styles and sizes available in the study
排除标准
- •Have tuberous breasts, congenital anomalies of the breast (e.g., Poland's Syndrome), or grade 3 ptosis
- •Have undergone any previous breast surgery
- •Have tissue covering determined inadequate or unsuitable by the surgeon
研究组 & 干预措施
All Participants
Experimental
Al participants who had new texture shaped breast implants surgically implanted.
干预措施: new texture shaped breast implants (Device)
结局指标
主要结局
Investigator Overall Satisfaction With the Device Using a 5-Point Scale
时间窗: 3 months
The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.
次要结局
- Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire(6 months)
- Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue(6 months)
- Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale(Interim analysis: 12 months)
- Percentage of Participants With Local Complications(Interim analysis: 12 months)
研究者
研究点 (4)
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