NCT01053052撤回不适用
A Comparative Study of Methods for Tubal Patency Determination and Uterine Cavity Evaluation: Sonography With the FemVue(TM) Catheter System vs. Hysterosalpingography (HSG)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Femasys Inc.
- 主要终点
- Concordance of evaluations of fallopian tube patency and intrauterine pathology.
研究概览
简要总结
Multi-center prospective comparison of fallopian tubal patency determination and uterine evaluation interventions using legally marketed devices for their intended purposes, and using each subject as their own control.
详细描述
Study cancelled prior to recruitment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 是
入选标准
- •Non-pregnant women between the ages of 18 and 45 who desire to know the patency status of the fallopian tubes and if the uterine cavity is free of pathology who have:
- •Been attempting conception for 6 months or
- •A history of PID (including the conditions listed below) or
- •Chlamydia
- •Gonorrhea
- •Endometriosis
- •A history of pelvic surgery or
- •Advanced maternal age (≥ 35) And
- •Negative test for Gonorrhea/Chlamydia or prophylactic antibiotic treatment
- •Without current bi-lateral tubal sterilization
- •Signed Informed Consent
排除标准
- •Uterine anomaly or lesion(s) preventing catheter placement for either the FemVue or HSG procedure(as identified and documented by TVUS Screening procedure or the uterine cavity evaluation during the FemVue procedure or any previous diagnostic procedure)
- •obstructing access to uterine cornu
- •distorting fundus at the midline region
结局指标
主要结局
Concordance of evaluations of fallopian tube patency and intrauterine pathology.
时间窗: Day 1
次要结局
- subject discomfort assessment(Day 1)
研究者
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