Design Optimization of RIVOS EUS Access Device - A Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- Other (Terminated)
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Technical success, defined as:
研究概览
简要总结
The study primary objective is to assess basic feasibility, safety, and performance in patients with malignant biliary obstruction (MBO) who are indicated to receive endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) for biliary drainage to contribute to design optimization of the RIVOS™ EUS Access Device. As this is a feasibility study with a low enrollment goal, there is no hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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 greater than 1.5 and not correctable.
- •presence of bleeding disorder.
- •platelets less than 50,000 mm cubed
- •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, defined as:
时间窗: Screening, Baseline, Day 0 Study Procedure, Day 1 Post-Study Procedure, Day 7 Post-Study Procedure
- Access of the target biliary duct, as confirmed via imaging, and
时间窗: Screening, Baseline, Day 0 Study Procedure, Day 1 Post-Study Procedure, Day 7 Post-Study Procedure
- Ability to advance a wire to guide the procedure through the access cannula after the sharp is removed, and
时间窗: Screening, Baseline, Day 0 Study Procedure, Day 1 Post-Study Procedure, Day 7 Post-Study Procedure
- Ability to create a cautery fistula for accessory device passage
时间窗: Screening, Baseline, Day 0 Study Procedure, Day 1 Post-Study Procedure, Day 7 Post-Study Procedure
2. Study device- and study procedure-related serious adverse events (SAEs)
时间窗: Screening, Baseline, Day 0 Study Procedure, Day 1 Post-Study Procedure, Day 7 Post-Study Procedure
3. Study device performance, evaluated per the following criteria:
时间窗: Screening, Baseline, Day 0 Study Procedure, Day 1 Post-Study Procedure, Day 7 Post-Study Procedure
- Ability to gain access to the target structure
时间窗: Screening, Baseline, Day 0 Study Procedure, Day 1 Post-Study Procedure, Day 7 Post-Study Procedure
- Ability to maintain access to the target structure
时间窗: Screening, Baseline, Day 0 Study Procedure, Day 1 Post-Study Procedure, Day 7 Post-Study Procedure
- Ability to visualize device during necessary procedural steps
时间窗: Screening, Baseline, Day 0 Study Procedure, Day 1 Post-Study Procedure, Day 7 Post-Study Procedure
次要结局
未报告次要终点
研究者
Sundeep Lakhtakia
Asian Institute of Gastroenterology