NCT01789489终止不适用
Contribution of 3D Sonohysterography and Virtual Hysteroscopy in Exploration of the Uterine Cavity in Comparison to the Diagnostic Hysteroscopy.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Polyps, fibrosis, atrophy, hypertrophy and other uterine pathology detected by 3D sonohysterography (Accuracy of uterine cavity exploration by 3D sonohysterography)
研究概览
简要总结
To prove that the 3 dimensional sonohysterography is, at least, as effective as the diagnostic hysteroscopy in examining the uterine cavity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnostic hysteroscopy prescribed either for a case of infertility or in case of doubt of endometrial / uterine pathology suspected by ultrasound or hysterography.
排除标准
- •Current Pregnancy.
- •Genital infection
研究组 & 干预措施
3 dimensional sonohysterography
Active Comparator
3 dimensional sonohysterography
干预措施: Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography) (Device)
Standard hysteroscopy
Active Comparator
Standard hysteroscopy
干预措施: Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography) (Device)
结局指标
主要结局
Polyps, fibrosis, atrophy, hypertrophy and other uterine pathology detected by 3D sonohysterography (Accuracy of uterine cavity exploration by 3D sonohysterography)
时间窗: 7 months
次要结局
未报告次要终点
研究者
研究点 (1)
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