Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 634
- 试验地点
- 2
- 主要终点
- Number of Adenomas Detected Per Colonoscopy (APC).
研究概览
简要总结
The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.
详细描述
This will be a prospective, randomized controlled study. Subjects referred for a screening, surveillance, or diagnostic colonoscopy will be prospectively enrolled. This study aims to compare the number of adenomas detected per colonoscopy (APC) between an Endocuff colonoscopy and an AmplifEYE colonoscopy.
It is estimated that the Endocuff Vision will result in an APC of 2.3. The investigators consider that a clinically acceptable ADR for the Medivators device would be within 20% of this value or 1.5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40 years of age or older
- •Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
- •Able to provide written informed consent
排除标准
- •Active Inflammatory Bowel Disease
- •Prior resection of the colon
- •Referred for resection of a polyp identified by another physician
- •Referred for a previous incomplete colonoscopy
结局指标
主要结局
Number of Adenomas Detected Per Colonoscopy (APC).
时间窗: During colonoscopy procedure
Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
次要结局
- Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))(During colonoscopy procedure)
- Complications Encountered During Procedure(During Colonoscopy procedure)
- Passage of Device Through Sigmoid Colon(during insertion portion of colonoscopy)
- Polyps Per Colonoscopy (PPC)(During colonoscopy procedure)
- Time Comparison for Each Method(During colonoscopy procedure)
- Cecal Intubation Rate(During Colonoscopy procedure)
- Detection of Serrated Lesions(During colonoscopy procedure)
研究者
Douglas K. Rex
Professor of Medicine
Indiana University