NCT02340650已完成不适用
High Resolution Imaging for Early and Better Detection of Bladder Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Specificity of Bladder Cancer Detection Imaging
研究概览
简要总结
The goal of this study is to develop, optimize, and validate a High Resolution Imaging System in the bladder that displays images in real-time, providing automated diagnostic criteria for bladder cancer screening. High resolution images of normal bladder tissue and suspicious bladder lesions will be collected from patients who present to the study site for clinical evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Diagnosed with clinically suspicious bladder lesion or clinical finding; or who are undergoing cystoscopy as part of their routine clinical care.
- •Must be willing and able to participate and provide written informed consent
- •Women of childbearing age who have the possibility of being pregnant must have a negative pregnancy test prior to participation
排除标准
- •Patient with sufficient evidence of cognitive impairment that limits the subject's ability to understand the protocol, provide informed consent, or to comply with the protocol procedures.
- •Women with the possibility of having the pregnancy.
- •Patients having acute infection.
- •Person with Lidocaine sensitivity.
结局指标
主要结局
Specificity of Bladder Cancer Detection Imaging
时间窗: baseline (at the time of imaging)
次要结局
未报告次要终点
研究者
Nadeem N Dhanani
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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