NCT02504411撤回不适用
Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy Versus Standard Colonoscopy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Adenoma detection rate (ADR) as determined by Colonoscopy
研究概览
简要总结
The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing first screening colonoscopy
- •Patients undergoing subsequent surveillance colonoscopies with known history of prior colon polyps detected on prior screening colonoscopies.
- •Ability to provide informed consent.
排除标准
- •Previous surgical resection of any part of the colon
- •history of colon cancer
- •history of inflammatory bowel disease
- •use of antiplatelet agents or anti-coagulants that precluded removal of polyps
- •Poor general condition
- •History of polyposis syndrome or hereditary nonpolyposis colorectal cancer
- •Inability to give informed consent.
结局指标
主要结局
Adenoma detection rate (ADR) as determined by Colonoscopy
时间窗: intraoperative
Complete adenoma resection rate (CARE) for adenoma > 10 mm in diameter as determined by Colonoscopy
时间窗: intraoperative
次要结局
- Cecal Intubation Rate (CIR)(intraoperative)
研究者
Nirav C Thosani
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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