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临床试验/NCT01384240
NCT01384240终止早期 1 期

Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Anandasabapathy, Sharmila, M.D.1 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2010年4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
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

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

Experimental

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

研究者

发起方
Anandasabapathy, Sharmila, M.D.
申办方类型
Indiv
责任方
Sponsor

研究点 (1)

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