NCT03767166已完成不适用
A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement
Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Biodegradation time
研究概览
简要总结
This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.
On procedure day, the study team will confirm that the patient meets all the inclusion criteria and none of the exclusion criteria.
The patient will undergo the ABS insertion and monitored and follow-up accordingly to biodegration variant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with an indication to position one ore more biliary plastic stents during ERCP
- •Patients with an indication to position a pancreatic plastic stent during ERCP
排除标准
- •Age < 18 y
- •Life expectancy < 1 m,
- •Inability to pass a guidewire through stricture
- •Contra-indication for endoscopy or interventional radiology
- •Presence of partial gastric resection
- •Unsigned informing consent form, ICF
- •Pregnancy
- •Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma
结局指标
主要结局
Biodegradation time
时间窗: 24 Months
次要结局
未报告次要终点
研究者
研究点 (1)
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