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Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray

2011年5月20日 更新者:Mayo Clinic
Tubal sterilization is the most prevalent form of contraception in the United States and the world. Currently, approximately half of these are performed with a laparoscope and half through a mini-laparotomy after delivery. Micro-insert hysteroscopic sterilization system received FDA approval for elective sterilization in 2003. Compared to other forms of female sterilization, this procedure is minimally invasive and does not require entering the abdominal cavity. In addition, it is at least as effective in preventing pregnancy as other forms of tubal occlusion. Given the distinct advantages of this method, it could become the preferred method of tubal sterilization for physicians and their patients. Currently, there is no published data concerning the appearance of the micro-inserts system using other imaging modalities that are commonly used in gynecologic practice. As the use of this device becomes more widespread it will be more commonly encountered in radiographic imaging performed as part of routine patient care. The main objective of this study is to provide important descriptive data concerning the ultrasonographic and x-ray appearance of the micro-insert hysteroscopic sterilization device. An additional objective of this study is to identify characteristics on plain film and ultrasound (US) that correlate with tubal occlusion or patency.

研究概览

研究类型

观察性的

注册 (实际的)

25

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Minnesota
      • Rochester、Minnesota、美国、55902
        • Mayo Clinic

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Twenty-five subjects for this study will be recruited from patients who have requested a form of permanent sterilization, and who, after considering all the options, choose the trans-cervical hysteroscopic sterilization for this end. Any subject who is deemed suitable for the micro-insert hysteroscopic sterilization system (Essure micro-insert system, Conceptus Incorporated, Mountain View, California) placement will be offered the opportunity to participate in the study. Consent will be documented on a Mayo Clinic patient consent form at the time the decision is made to schedule the procedure.

描述

Inclusion Criteria:

  • Adult patients requesting sterilization

Exclusion Criteria:

  • Unsuccessful placement of the hysteroscopic sterilization system in one or both fallopian tubes. In addition, a patient will not be offered the opportunity to participate in the study if there are any conditions that would preclude attempted placement of the hysteroscopic sterilization system. These include hypersensitivity to nickel-titanium or contrast media, current or recent pregnancy (within the previous six weeks), active genital tract infection, prior tubal ligation, or known congenital uterine malformation.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Study Group
Twenty-five subjects for this study will be recruited from patients who have requested a form of permanent sterilization, and who, after considering all the options, choose the trans-cervical hysteroscopic sterilization for this end. Any subject who is deemed suitable for the micro-insert hysteroscopic sterilization system (Essure micro-insert system, Conceptus Incorporated, Mountain View, California) placement will be offered the opportunity to participate in the study.
Placement of micro-inserts transcervically with the aid of a hysteroscope
Performed immediately after micro-inserts placement and at 3 months
Performed immediately after micro-inserts placement and at 3 months.
Performed 3 months after micro-inserts placement

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Abimbola O. Famuyide, M.D.、Mayo Clinic, Rochester, MN

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年2月1日

初级完成 (实际的)

2006年3月1日

研究完成 (实际的)

2006年3月1日

研究注册日期

首次提交

2007年12月22日

首先提交符合 QC 标准的

2007年12月22日

首次发布 (估计)

2008年1月8日

研究记录更新

最后更新发布 (估计)

2011年5月23日

上次提交的符合 QC 标准的更新

2011年5月20日

最后验证

2011年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 628-04

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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