NCT04261608已完成不适用
A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 225
- 试验地点
- 6
- 主要终点
- Number of participants who experienced adverse events
研究概览
简要总结
This study is a retrospective chart review and entails review of medical records of patients enrolled in about 5 hospitals/clinics in China, and who have undergone breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019. The safety of McGhan breast implants (textured and smooth) will be evaluated based on occurrence of local complications including capsular contracture, malposition of implant, seroma/late seroma and anaplastic large cell lymphoma (ALCL).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who underwent breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019
排除标准
- 未提供
结局指标
主要结局
Number of participants who experienced adverse events
时间窗: up to 4 years
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Retrospective Chart Review of ValstarCarcinoma in Situ of BladderNCT01304173Endo Pharmaceuticals113
已完成
不适用
A Retrospective Chart Review of Deceased Patients With Mucopolysaccharidosis Type IIIBMPS IIIB (Sanfilippo Syndrome)NCT02293382Alexion Pharmaceuticals, Inc.30
已完成
不适用
A Retrospective Non-Interventional Study to Evaluate the Impact of Eculizumab in Korean PNH PatientsPNHNCT05337683Handok Inc.80
终止
不适用
Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing SyndromeHypercortisolismCushing SyndromeNCT03379363Corcept Therapeutics2
已完成
不适用
Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received AlpelisibPIK3CA-Related Overgrowth Spectrum (PROS)NCT04285723Novartis Pharmaceuticals57