Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure
研究概览
简要总结
The objective of this study is to confirm procedural performance of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.
详细描述
The main objective of this study to confirm the design and operating specifications of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures in study subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •18 years or older
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- •Scheduled for a clinically indicated endoscopic retrograde cholangiopancreatography (ERCP)
排除标准
- •Altered pancreaticobiliary anatomy
- •Potentially vulnerable subjects, including, but not limited to pregnant women
- •Subjects for whom endoscopic techniques are contraindicated
- •Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
- •Investigator discretion
研究组 & 干预措施
Exalt DScope 01B
Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
干预措施: Exalt Model D Single-Use Duodenoscope (Device)
结局指标
主要结局
Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure
时间窗: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure". Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.
次要结局
- Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope(Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.)
- Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure(SAEs are assessed through 7 days after the procedure.)
- Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope(Crossover is monitored throughout the procedure (within 24 hours on study day 1).)