NCT03942965Unknown不适用
Multi-center Prospective Registry Study Utilizing a Double Balloon Accessory Device to Facilitate Endoscopic Polypectomy in Large Intestine.
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Lumendi, LLC
- 入组人数
- 165
- 试验地点
- 3
- 主要终点
- Ability to perform the procedure safely and effectively with the study device.
研究概览
简要总结
This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s)
- •Patients capable of giving informed consent in English
- •No medical contraindication to endoscopic mucosal resection or endoscopic submucosal disection
排除标准
- •No patients less than 18 years of age.
- •Any contraindication to colonoscopy with due to subject's colon anatomy (i.e. stricture)
- •History of open or laparoscopic colorectal surgery
- •History of Inflammatory Bowel Disease
结局指标
主要结局
Ability to perform the procedure safely and effectively with the study device.
时间窗: Intraoperatively
Investigator answers yes or no
次要结局
- Number of Study Subjects with Treatment Related Adverse Events(Up to 30 days)
- Time to reach target lesion(Intraoperatively)
- Time to remove lesion after intervention begins(Intraoperatively)
- Total time using study device during case(Intraoperatively)
- Total case time(Intraoperatively)
- Total defect closure time(Intraoperatively)
- User feedback on device performance(Intraoperatively)
研究者
研究点 (3)
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