Outpatient Colonoscopy: Demonstrating Effective Salvage of Inadequate Colonoscopies Utilizing the Pure-Vu EVS System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Rate of incomplete colonoscopies
研究概览
简要总结
The aim of this study is to demonstrate that the use of the Pure-Vu EVS System can salvage inadequately prepared optical colonoscopies (OCs) to adequate OCs.
详细描述
The primary objective of this study is to demonstrate the reduction of inadequate colonoscopies when Pure-Vu EVS System is used to salvage inadequately prepped colons as defined by the multi-society guidelines (USMSTF).
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible adults aged between 40-80
- •Elective outpatient colonoscopy by participating gastroenterologist
排除标准
- •Not competent to consent
- •Known or suspected bleeding disorders such as, but not limited to hemophilia and von Willebrand disease
- •History of colonic resection
- •Prior incomplete colonoscopy due to patient anatomy
- •Diverticulitis
- •Active Inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
- •Known or suspected colon stricture
- •Hereditary Colorectal Cancer Syndrome
- •Subject is pregnant or suspected pregnant
结局指标
主要结局
Rate of incomplete colonoscopies
时间窗: Day 0 (Procedure Day)
Rate of incomplete colonoscopies due to inadequate preparation salvaged to adequate colonoscopies with the use of the Pure-Vu EVS System. Inadequate OCs defined as such if any of the following are met: * BBPS \< 6 (Adequacy is defined as BBPS of 2 or greater in each segment) * Inability to identify \> 5mm polyps The estimated rate of salvaged preparations will be calculated and presented with exact one-sided 95% confidence interval: Number of preps inadequate with SOC and adequate after Pure-VU EVS System / Number of preps inadequate with SOC. The lower bound will be compared to a 35% performance goal.
次要结局
- Assessment Screening(Day 0 (Procedure Day))
- Assessment of Screening(Day 0 (Procedure Day))
- Procedural Outcome(Day 0 (Procedure Day))
- Assessment screening(Day 0 (Procedure Day))
- Procedural Outcomes(Day 0 (Procedure Day))