Real World Study of Exalt D Single-use Duodenoscope in ERCP Procedures in China
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of patients complete the ERCP procedure
研究概览
简要总结
Study Objective(s)：This study is to evaluate the feasibility, preliminary safety and performance of Exalt D Single-use Duodenoscope in ERCP procedures in China, to generate local real world data from a Chinese ERCP population.
Study Design：Prospective, single-arm study Planned Number of Subjects：Up to 35 to satisfy 30 treated cohort Primary Endpoint：Ability to complete the ERCP procedure for the intended indication(s) without crossing to reusable duodenoscope.
It is also considered as Exalt D's ability if the clinical effect is the same per the investigator's judgement in case of an endoscope change (non-Exalt D).
详细描述
Device Description：The Exalt™ Model D Single-Use Duodenoscope is a sterile, single-use endoscope that facilitates access to the duodenum, delivery of accessories, and live video when connected to an Exalt™ Controller.
The Exalt™ Controller is an electronic device that:
- Receives video signals from a Boston Scientific single-use endoscope,
- Processes the video signals,
- Outputs video images to a video monitor, and
- Outputs electrical signal(s) that interface with external image capture systems.
Study Design：This is a prospective, single-arm study with up to 35 subjects to satisfy 30 treated cohort in up to 3 centers. The study duration is expected to be approximately 7 months, assuming 6 months enrollment and 1 month follow up. The study duration for each subject is expected to be approximately 30 days.
Data Analyses：All statistical analyses will be done using The SAS System software, version 8 or higher (Copyright © 2000 SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513, USA. All rights reserved).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Schedule for a clinically indicated ERCP
排除标准
- •Potentially vulnerable subjects, including, but not limited to pregnant women
- •Subjects for whom endoscopic techniques are contraindicated
- •Subjects 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
结局指标
主要结局
Number of patients complete the ERCP procedure
时间窗: During the procedure
Ability to complete the ERCP procedure for the intended indication(s) without crossing to reusable duodenoscope. It is also considered as Exalt D's ability if the clinical effect is the same per the investigator's judgement in case of an endoscope change (non-Exalt D).
次要结局
- Endoscopist qualitative rating(During the procedure)