NCT05862948已完成不适用
Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy - ACCENDO-Colo Study
Fondazione Poliambulanza Istituto Ospedaliero4 个研究点 分布在 1 个国家目标入组 1,160 人开始时间: 2021年10月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,160
- 试验地点
- 4
- 主要终点
- Adenoma detection rate (ADR)
研究概览
简要总结
The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years or ≤85
- •Patients undergoing screening, follow-up, or diagnostic colonoscopy
排除标准
- •Suspected or known inflammatory bowel disease
- •Colonic resection
- •Taking anticoagulants or antiaggregants that contraindicate the performance of therapy
- •Patients with incomplete colonoscopy
- •Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate.
- •Inability to provide informed consent.
结局指标
主要结局
Adenoma detection rate (ADR)
时间窗: 1 years
ADR defined as the proportion of patients with at least 1 adenoma detected.
次要结局
- Polyp per colonoscopy (PPC)(1 years)
- Adenoma per colonoscopy (APC)(1 years)
- Polyp detection rate (PDR)(1 years)
- Sessile serrated lesion detection rate (SSLDR)(1 years)
- Advanced adenoma detection rate (AADR)(1 years)
研究者
研究点 (4)
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