NCT01384227已完成早期 1 期
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
Anandasabapathy, Sharmila, M.D.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年2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
- 40
- 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 barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in Barrett's 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
- •Barrett's without dysplasia
- •Barrett's with dysplasia
- •Esophageal Adenocarcinoma
排除标准
- •Subjects unfit for standard upper endoscopy
- •Subjects currently receiving chemo or radiation treatment
- •Subject currently receiving PDT or ablation
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 is neoplastic or non-neoplastic
时间窗: 1 day
次要结局
未报告次要终点
研究者
Sharmila Anandasabapathy, MD
Associate Professor of Medicne
Anandasabapathy, Sharmila, M.D.
研究点 (1)
Loading locations...
相似试验
已完成
早期 1 期
Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell CancerSquamous Cell CancerNCT01384708Anandasabapathy, Sharmila, M.D.70
终止
早期 1 期
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal NeoplasiaColon PolypsColonic DysplasiaAnal DysplasiaNCT01384240Anandasabapathy, Sharmila, M.D.183
终止
早期 1 期
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1GERDBarrett's EsophagusNCT01384695Anandasabapathy, Sharmila, M.D.67
Unknown
2 期
Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal AdenocarcinomaBarrett's EsophagusNCT02018367Anandasabapathy, Sharmila, M.D.100
Unknown
2 期
High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell NeoplasiaSuspected or Known Squamous Cell NeoplasiaPrior History of Squamous Cell Dysplasia and /or NeoplasiaNCT02029937Anandasabapathy, Sharmila, M.D.1,300