A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- to determine whether tissue is neoplastic 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 gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient 18 years or older
- •colonoscopy for screening or surveillance of polyps or disease of colon
- •anoscopy because of suspected or known anal dysplasia or neoplasia
排除标准
- •patient unable to provide informed consent
- •patient found unfit for standard colonoscopy or anoscopy with biopsies
研究组 & 干预措施
Fluorescein
Confocal imaging using contrast agent fluorescein
干预措施: Proflavine hemisulfate (Drug)
Proflavine hemisulfate
confocal imaging using contrast agent proflavine
干预措施: Fluorescein (Drug)
结局指标
主要结局
to determine whether tissue is neoplastic or non-neoplastic
时间窗: 1 day
次要结局
未报告次要终点