Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 526
- 试验地点
- 20
- 主要终点
- Procedural success for indeterminate strictures or undefined filling defects
研究概览
简要总结
The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age 18 or older.
- •Willing and able to provide written informed consent to participate in the study.
- •Willing and able to comply with the study procedures.
- •Indicated for ERCP and cholangioscopy or indicated for ERCP with suspected need for cholangioscopy.
排除标准
- •Endoscopic techniques are contraindicated.
- •ERCP is contraindicated
- •A medical condition that warrants the use of the device outside of the indication for use.
- •Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
结局指标
主要结局
Procedural success for indeterminate strictures or undefined filling defects
时间窗: Procedure - the average expected duration of the procedure is 1.5 hours
For indeterminate strictures or undefined filling defects cases procedural success is defined as 1) ability to visualize stricture or defect, and 2) ability to provide visual impression of malignancy, and 3) when applicable, ability to obtain SpyBite biopsy adequate for histology
Procedural success for other indications
时间窗: Procedure - the average expected duration of the procedure is 1.5 hours
For other indications procedural success is defined as ability to establish diagnosis and /or complete therapy in the following categories: 1) pre-operative assessment of extent of peri-ampullary and biliary tumors, 2) selective guidewire placement, 3) assessment of unexplained hemobilia, 4) assessment of portal biliopathy, 5) assessment of intraductal biliary ablation therapy, 6) extraction of migrated stents, or 7) other.
Procedural success for biliary stone cases
时间窗: Procedure - the average expected duration of the procedure is 1.5 hours
For biliary stone cases procedural success is defined as 1) ability to visualize the stone(s), and 2) ability to successfully initiate stone fragmentation, and 3) ability to achieve stone clearance in one or more SpyGlass procedures.
次要结局
- Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure.(Procedure - the average expected duration of the procedure is 1.5 hours)
- For patients undergoing SpyBite biopsy: correlation between number of biopsies and conclusive histopathology of SpyBite biopsies.(Procedure to 6 months)
- Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP(Procedure - the average expected duration of the procedure is 1.5 hours)
- For patients undergoing stone management: incidence of visualization of stones not suspected during previous ERCP.(Procedure - the average expected duration of the procedure is 1.5 hours)
- Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure(Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit)
- For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance.(Procedure - the average expected duration of the procedure is 1.5 hours)
- For patients undergoing stone management: correlation between stone size and ability to reach stone clearance in one SpyGlass session.(Procedure - the average expected duration of the procedure is 1.5 hours)