Effectiveness of EndoCuff Vision in Improving Adenoma Detection Rate in a Large Screening-Related Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,816
- 试验地点
- 1
- 主要终点
- Adenoma detection rate (ADR)
研究概览
简要总结
The goal of distal attachment devices is to enhance an endoscopist's adenoma detection rate (ADR). A device called EndoCuff Vision (ECV) has been introduced that employs a single row of flexible arms to evert colonic folds, thus optimizing mucosal visualization and enhancing ADR. ECV has been shown to be efficacious in improving ADR within the context of randomized trials. However, no 'real-world' studies have been published assessing the effectiveness of ECV in non-trial settings. The primary objective of this study is to assess the effect of ECV use on ADR in a routine screening-related population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •adult patients undergoing colonoscopy.
排除标准
- •single balloon- or double balloon-assisted colonoscopy;
- •planned advanced polypectomy or endoscopic mucosal resection (EMR);
- •planned endoscopic post-polypectomy or post-EMR surveillance;
- •known active diverticulitis;
- •known colonic stricture.
结局指标
主要结局
Adenoma detection rate (ADR)
时间窗: Intra-procedural
Proportion of an endoscopist's screening-related colonoscopies during which one or more adenoma was biopsied or removed
次要结局
- Adenoma detection rate among patients with positive fecal immunochemical tests(Intra-procedural)
- Nurse-assessed patient comfort scores (NAPCOMs)(Intra-procedural)
- CIR (cecal intubation rate)(Intra-procedural)
- Procedure time(Intra-procedural)
- Number of patients with immediate adverse events(Day 1)
- SSADR (sessile serrated adenoma detection rate)(Intra-procedural)
- Number of patients with delayed adverse events(Within 30 days of index procedure)