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Adiana Post-Approval Clinical Study (APACS) (APACS)

2012年10月19日 更新者：Hologic, Inc.

Adiana Post-Approval Clinical Study

The Adiana Post-Approval Clinical Study (APACS) has been designed to compile information on the efficacy and safety of the Adiana Permanent Contraception System in the post market setting. Specifically, data will be collected that is relevant to the evaluation of the safety and efficacy of the Adiana System for women who desire permanent birth control by occlusion of the fallopian tubes. This study is an observational study that is not intended to test specific hypotheses.

研究概览

地位

终止

条件

详细说明

Adiana Post-Approval Clinical Study is a prospective, single armed, multi-center, observational study that is designed to provide additional efficacy and safety data regarding the FDA-approved Adiana Permanent Contraception System. This study will be conducted at 8-10 clinical sites and enroll 1000 subjects. Enrolled subjects will have baseline data collected at the time of their Adiana procedure and will then be followed for a period of 2 years with visits occurring at 3 months following the Adiana procedure, 6 months following Adiana procedure (as applicable), 12 and 24 months post relying date.

研究类型

观察性的

注册 (实际的)

169

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

  • 美国
    • California
      • Elk Grove、California、美国、95758
        • Sutter Medical Group
    • Illinois
      • Arlington Heights、Illinois、美国、60004
        • WomenCare, P.C.
    • Missouri
      • Columbia、Missouri、美国、65203
        • University of Missouri Health Care
    • North Carolina
      • Winston-Salem、North Carolina、美国、27103
        • Valaoras & Lewis Obstetrics and Gynecology
    • Ohio
      • Columbus、Ohio、美国、43231
        • Complete Healthcare For Women
    • Oregon
      • Redmond、Oregon、美国、97756
        • The Women's Center of Central Oregon
      • Salem、Oregon、美国、97302
        • Salem Women's Clinic
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15224
        • Western Pennsylvania Hospital
    • Virginia
      • Danville、Virginia、美国、24541
        • Ob/Gyn Associates of Danville

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 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Women, 18 - 45 years old, at risk for pregnancy, that are seeking permanent contraception using the Adiana Permanent Contraception System.

描述

Inclusion Criteria:

  • Subjects who are seeking permanent sterilization
  • Women 18-45 years old
  • Subjects who are at risk of becoming pregnant
  • Subjects willing to use alternative contraception for at least three (3) months following device placement and bilateral tubal occlusion is confirmed by HSG
  • Subjects who are able to provide informed consent

Exclusion Criteria:

  • Subjects who are uncertain about their desire to end fertility
  • Clinical evidence of an active pelvic infection or history of a recent pelvic infection
  • Has intra-uterine pathology which would prevent access to either tubal ostium or the intramural portion of either fallopian tube (i.e., large submucous fibroids, uterine adhesions, apparent uni or bilateral proximal tubal occlusion, suspected unicornuate uterus, etc.)
  • Is pregnant (as evidenced by pregnancy test result) or suspects pregnancy
  • Is currently less than three (3) months since her last pregnancy
  • Has previously undergone a tubal ligation
  • Is currently taking immunosuppressive medication (e.g., steroids)
  • Has a known allergy to contrast media
  • Has external pacemaker or internal cardioverter defibrillator
  • Subject is unable to follow the protocol and return for follow up visits
  • In the opinion of the investigator, the subject has a medical condition that precludes safe participation in the study

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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.
大体时间：At one and two years
The primary efficacy endpoints are the one and two year pregnancy rates among women who have hysterosalpingogram (HSG)-proven bilateral occlusion and are informed that they may rely on the Adiana System for contraception.
At one and two years

次要结果测量

结果测量
措施说明
大体时间
Safety Endpoints
大体时间：At one and two years
The Adiana System will be evaluated for safety on the basis of the occurrence of adverse events which are related to the study device, unanticipated or serious.
At one and two years

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

Hologic, Inc.

调查人员

  • 研究主任：Edward Evantash, MD、Hologic, Inc.

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

2010年8月1日

研究完成 (实际的)

2012年4月1日

研究注册日期

首次提交

2010年8月5日

首先提交符合 QC 标准的

2010年8月6日

首次发布 (估计)

2010年8月9日

研究记录更新

最后更新发布 (估计)

2012年11月20日

上次提交的符合 QC 标准的更新

2012年10月19日

最后验证

2012年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • S0210001

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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