Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder
研究概览
简要总结
Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 14 years old
- •Benign tracheoesophageal fistulas identified through bronchoscopy;
排除标准
- •Malign neoplasia
- •Current mechanical ventilation
- •Immunosuppressed
- •Current local inflammatory process at fistulas borders
- •Other clinical risk factors
研究组 & 干预措施
Fistula closure with occluder
Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.
干预措施: Fistula closure with Gore Helex Septal Occluder (Device)
Fistula closure with occluder
Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.
干预措施: Gore Helex Septal Occluder (Device)
结局指标
主要结局
Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder
时间窗: 6 months
The closure will be confirmed by endoscopic or bronchoscopic observation of the fistula at regular intervals: one week, two weeks, and four weeks after implant of the occluder. A thorax CT scan will ascertain correct positioning and stability of the occluder.
次要结局
未报告次要终点
研究者
Miguel L. Tedde
MD, PhD
University of Sao Paulo