Design Optimization of RIVOS EUS Access Device - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Technical Success
研究概览
简要总结
The goal of this clinical trial is to assess basic feasibility, safety, and performance of an EUS access device in patients with malignant biliary obstruction who are indicated to receive EUS-guided hepaticogastrostomy for biliary drainage. The main questions it aims to answer are:
- Can the device be used to gain and maintain access to target anatomy?
- Does the device have a clinically acceptable safety profile?
- How does the device perform overall?
All patients will undergo a hepaticogastrostomy procedure and be followed for 7 days post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Patient with malignant biliary obstruction and who is indicated to receive EUS-guided hepaticogastrostomy for biliary drainage, as documented by dilated left hepatic duct and hyperbilirubinemia
- •Patient who failed ERCP (e.g., inability to access the obstructed biliary system via a transpapillary route) or for whom ERCP is not an option (e.g., due to altered anatomy, gastric outlet obstruction)
- •18 years of age or older
- •Patient willing and able to provide written informed consent and comply with specified study visits
排除标准
- •Patient whose general medical condition and degree of respiratory failure would not allow them to tolerate endoscopy and/or the manipulation required to perform the study procedure
- •Abnormal coagulopathy:
- •INR >1.5 and not correctable
- •presence of bleeding disorder
- •platelets <50,000 mm3
- •Patient with contraindication to use of electrical devices
- •Female of childbearing potential with a positive pregnancy test prior to the procedure or who intends to become pregnant during the study
- •Patient from a vulnerable population
- •Current participation in another investigational drug or device study that could interfere with the endpoints of this study
结局指标
主要结局
Technical Success
时间窗: Day 0 Study Procedure
Defined as (1) access of the target biliary duct, as confirmed via imaging, (2) ability to advance a wire to guide the procedure through the access cannula after the sharp is removed, and (3) ability to create a cautery fistula for accessory device passage
Safety
时间窗: Day 0 Study Procedure through Day 7 Post-Study Procedure
Study device- and study procedure-related serious adverse events
Device Performance
时间窗: Day 0 Study Procedure
Evaluated per the following criteria (1) ability to gain access to the target structure, (2) ability to maintain access to the target structure, (3) ability to visualize device during necessary procedural steps, and (4) ability to create a cautery fistula for accessory device passage
次要结局
未报告次要终点