NCT00613262Unknown不适用
A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging
Midwest Biomedical Research Foundation2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome.
研究概览
简要总结
The investigators hypothesize that NBI will have a high accuracy in predicting polyp histology real time during a colonoscopy by visualization of the surface mucosal and vascular patterns. Aim#1: To determine the sensitivity, specificity and accuracy of NBI and standard white light colonoscopy for predicting polyp histology by evaluating the surface mucosal and vascular patterns during colonoscopy. Aim#2: To determine the inter-observer agreement between investigators for the recognition of various polyp patterns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •referral for screening or surveillance colonoscopy
- •the ability to provide informed consent
排除标准
- •prior surgical resection of any portion of colon
- •prior history of colon cancer
- •history of inflammatory bowel disease
- •use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
- •poor general condition or any other reason to avoid prolonged procedure time
- •history of polyposis syndrome or Hereditary Non-polyposis colon cancer
- •inability to give informed consent
结局指标
主要结局
The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Amit Rastogi
Principal Investagator
Midwest Biomedical Research Foundation
研究点 (2)
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