Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- to determine whether tissue in nepoplastic or non-neoplastic
研究概览
简要总结
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.
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
- •surveillance of polyps or disease of the colon
- •screening colonoscopy
- •anoscopy for suspected or known anal dysplasia or neoplasia
排除标准
- •unfit for standard colonoscopy or anoscopy
- •unable to provide informed consent
研究组 & 干预措施
Proflavine Hemisulfate
干预措施: Proflavine Hemisulfate (Drug)
结局指标
主要结局
to determine whether tissue in nepoplastic or non-neoplastic
时间窗: 1 day
次要结局
未报告次要终点
