NCT01750970已完成不适用
Endoscopic Resection of High Grade(TA, T1, Cis)Non-muscle Invasive Bladder Tumors: Modification of Usual Management of This Resection by Using the Blue Light and Evaluation of the Outcome: Should we Maintain the Dogma of Second Endoscopic Resection as a Principle?
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Number of extra lesions revealed by blue light compared to the resection performed in white light
研究概览
简要总结
To confirm the benefit of endoscopic resection under fluorescence and blue light of high grade non-muscle invasive bladder tumor, and verifying if the second endoscopic resection recommended nowadays can be deleted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •18 year-old and older male and female subjects having high grade non-muscle invasive bladder tumor, with urinary cytology , imaging examination (Ultrasound, urography, or scan) and endoscopic examination
排除标准
- •Less than 18 years of age, and having no:
- •Non-muscle invasive tumor, and of low grade.
- •Bladder tumor infiltrating the muscular layer shown by pre-operative test, with absence of urinary cytology
- •No blue light source in sustainable way
研究组 & 干预措施
Resection under blue light
Experimental
干预措施: Endoscopic resection under blue light (Hexvix®) (Other)
Resection under white light
Active Comparator
干预措施: Endoscopic resection under blue light (Hexvix®) (Other)
结局指标
主要结局
Number of extra lesions revealed by blue light compared to the resection performed in white light
时间窗: 2 to 6 weeks after resection
次要结局
未报告次要终点
研究者
研究点 (1)
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