NL-OMON45632撤回2 期
Esophageal stent BD-Covered for refractory benign esophageal strictures: a safety and efficacy study - BD-Covered: safety and efficacy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •* Age * 18 years
- •* Willingness to participate voluntarily in the study and give written informed consent
- •* Refractory benign esophageal stricture with or without fistulae, i.e. the patient has to be treated with a minimum of 2 and no maximum of esophageal dilation sessions to the minimal diameter of 15-mm, using a balloon dilator or Savary bougie.
- •* Ability to undergo periodic endoscopic follow-up
排除标准
- •* Pregnancy or breastfeeding
- •* Simultaneous participation in another clinical study
- •* Life expectancy of less than 12 months
- •* Malignant esophageal stricture
- •* Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
研究者
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