NCT01384708已完成早期 1 期
Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer
Anandasabapathy, Sharmila, M.D.1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- to determine whether or not tissue is neoplastic or non-neoplastic
研究概览
简要总结
The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collaborators at Rice University and provides > 1000x magnified images of the esophageal mucosa. The purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •known or suspected squamous cell neoplasia
- •18 years or older
排除标准
- 未提供
研究组 & 干预措施
treatment
Experimental
imaging with proflavine
干预措施: proflavine (Drug)
结局指标
主要结局
to determine whether or not tissue is neoplastic or non-neoplastic
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (1)
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