Can Contrast Infused Sonography Using Air Bubbles Replace Hysterosalpingogram as the Diagnostic Evaluation of Fallopian Tube Patency Following Hysteroscopic Sterilization Using Essure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Fallopian Tube Patency - HyCoSy vs HSG
研究概览
简要总结
The study evaluates whether saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) is as good as or better than X-ray hysterosalpingography (HSG) for determining whether fallopian tubes are open or closed in patients who are undergoing an Essure confirmation test.
详细描述
The gold standard for evaluating whether fallopian tubes are open versus closed is the X-ray hysterosalpingography (HSG). HSG is a radiologic procedure that is performed to verify that placement of the Essure tubal ligation inserts have successfully blocked the fallopian tubes. However, this procedure involved exposure to radiation. The saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) does not involve radiation and can be done in a physician's office. The HyCoSy air bubble device may be a lower cost, safer alternative procedure if it can be shown to provide similar results for tubal patency.
This study will compare the HyCoSy procedure results with the HSG procedure results in women who require the HSG procedure after receiving Essure tubal ligation inserts for their Essure confirmation test.
Women will be randomized to receive the HycoSy procedure first, followed by the HSG procedure or to the reverse order. Two independent readers will review the video results for both procedures to determine the degree of agreement on tubal patency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor does not know which procedure was received first or second.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Documentation of normal Pap smear within 1 year prior to enrollment into study.
- •Written informed consent given
- •Need for evaluation of tubal status for post-Essure tubal occlusion
- •Negative urine pregnancy test
排除标准
- •History of unresolved dysfunctional uterine bleeding (DUB).
- •History of a hysterectomy.
- •Current urogenital disease.
- •History of allergic response to IVP dye (exclusion for HSG).
- •Abnormal pap smear.
- •Positive urine pregnancy test.
结局指标
主要结局
Fallopian Tube Patency - HyCoSy vs HSG
时间窗: At time of procedure
Observed flow of fluid/bubbles through fallopian tubes.
次要结局
- Physician Evaluation of Uterine Cavity(At time of HyCoSy procedure)
- Pain Scores(At time of procedures)