NL-OMON31943撤回不适用
Clinical investigation of the safety and efficacy of ALIMAXX-B biliary stent for bile duct obstruction - ALIMAXX-B safety and efficacy
Alveolus, Inc.0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 10
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 99（—）
入选标准
- •a. Malignant obstructive disease at the level of the extrahepatic CBD
- •b. Willing and able to comply with study procedures and provide written informed consent
- •c. > 18 years of age presenting with biliary obstruction
排除标准
- •a. Benign obstruction of the CBD
- •b. Malignancy involving intrahepatic ducts or duodenum
- •c. Stricture >8cm in length
- •d. Inability to pass a guidewire through the stricture area
- •e. Prior biliary stent
- •f. Perforation of any duct within the biliary tree
- •g. Life expectancy of <90 days
- •h. Disease that is amenable to curative resection
- •i. INR > 1.5
- •j. Prior gastric bypass or biliroth type I or type II gastric resection
研究者
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