NCT01816373已完成不适用
Efficacy Evaluation of the Non-invasive Negative Pressure Treatment for Pectus Excavatum
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Measurement of the reduction in the deepness of the pectus excavatum
研究概览
简要总结
The purpose of this study is to determine whether the non-invasive negative pressure treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum treatment
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
- 8 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •absence of co-morbidities that may interfere with proper placement or function of the apparatus
- •test negative for pregnancy in women of childbearing age
排除标准
- •skeletal diseases like osteogenesis imperfecta or osteoporosis
- •clotting disorders such as hemophilia or thrombopathia
- •skin diseases or infections of the anterior chest wall
- •angiopathies or vascular fragility
- •obesity important with BMI greater than 30
- •precarious commitment to the prolonged use of the device protocol
结局指标
主要结局
Measurement of the reduction in the deepness of the pectus excavatum
时间窗: 3 months
The patients will be submitted to clinical measurement of their anterior chest wall at three months interval until the closing of the study
次要结局
- Evaluation of quality of life related to self-esteem(One year)
研究者
Miguel L. Tedde
MD, PhD
University of Sao Paulo
研究点 (4)
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