Initial Case Series With Exalt Single-Use Duodenoscope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Successful ERCP procedure
研究概览
简要总结
To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.
详细描述
This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. 35-70 cases will be included at up to 10 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 7 days after their 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
- •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 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 01
Subjects will have a clinically indicated per standard of care ERCP 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
Successful 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
- Incidence of crossover from Exalt single-use duodenoscope to reusable duodenoscope(Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).)
- Endoscopist qualitative rating(Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure (within 24 hours on study day 1).)
- Evaluation of adverse events (SAEs) related to the device and/or the procedure(SAEs are assessed through 7 days after the procedure.)