NCT01836588Unknown不适用
New Gentle Biopsy Method of Cervix Lesions Using Superficial Curettage/Protocol ID: CX-CUR
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- pathological comparative results and all cause mobidity
研究概览
简要总结
It is to investigate to what extent a gentle tissue extraction of CIN lesions of the cervix will bring the same conclusion than the conventional cervix biopsy, but with less pain and morbidity, after patients were undergoing a conisation in order to treat CIN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 80
- •Karnofsky-Index of 80 and higher
- •Cytological suspicious CIN and a colposcopical impression of a major lesion (therapeutical endpoint: conisation)
排除标准
- •Former malign disease oft he pelvic organs
- •Pregnancy
- •Serious internistic diseases
- •Drug addiction
结局指标
主要结局
pathological comparative results and all cause mobidity
时间窗: 1 year
The comparison of these two methods to show that the pathologic diagnostical results are alike and the morbidity is less.
次要结局
未报告次要终点
研究者
Tim Schellenberg
physician
Charite University, Berlin, Germany
研究点 (2)
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