Essure (Model ESS310) Placement Rate Study
2021年4月6日 更新者：Bayer
A Multi-Center, United States Clinical Study to Evaluate Placement Success of the ESS310 Essure® System
To evaluate the safety and successful placement rate of Essure Model ESS310 device and any factors that may influence the successful placement rate of this device.
研究概览
研究类型
介入性
注册 (实际的)
134
阶段
- 第三阶段
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
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Arizona
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Glendale、Arizona、美国、85304
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Phoenix、Arizona、美国、85015
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Colorado
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Colorado Springs、Colorado、美国、80923
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Georgia
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Augusta、Georgia、美国、30909
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Indiana
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Fort Wayne、Indiana、美国、46825
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Newburgh、Indiana、美国、47630
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Michigan
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Grand Blanc、Michigan、美国、48439
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Saginaw、Michigan、美国、48604
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Southfield、Michigan、美国、48034
- Wayne State University Physicians Group
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic - Rochester
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North Carolina
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Winston-Salem、North Carolina、美国、27103
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Ohio
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Dayton、Ohio、美国、45409-2793
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt University Medical Center
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Nashville、Tennessee、美国、37205
- Tennessee Women's Care, PC
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Texas
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Fort Worth、Texas、美国、76104
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Houston、Texas、美国、77074
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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
21年 至 44年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Females aged range 21 to 44 years
- Subjects seeking permanent contraception
- Subjects with body weight within range of 90-300 pounds (40 - 136 kilograms)
- Subjects for whom medical history indicates bilateral viable and patent fallopian tubes
- Subjects are able and willing to comply with the protocol required follow-up visits
- Subjects have fulfilled local requirements for counseling and consent to contraception and sterilization, including any required waiting periods
- Subjects provide written informed consent prior to enrolment
- Subjects who have sufficient mental capacity to understand the informed consent form (ICF), comply with the protocol requirements, and provide clinically relevant and reliable feedback regarding their experience implant and subsequent wearing of the device
- Subjects who agree that anonymized personal data will be made available to study Sponsor and requisite regional and international regulatory bodies
Exclusion Criteria:
- Subjects suspected of being or confirmed pregnant
- Subjects post-partum or undergone pregnancy termination ≤6 weeks of scheduled insert placement
- Subjects who have known proximal tubal occlusion in either fallopian tube
- Subjects who have undergone fallopian tube sterilization procedure
- Subjects who have had total or partial salpingectomies
- Subjects diagnosed with tubal, endometrial, or myometrial pathology which may prevent fallopian tube ostia access
- Subjects diagnosed with unicornuate uterus
- Subjects diagnosed with active or currently being treated upper or lower pelvic infection
- Subjects with gynecologic malignancy
- Subjects who are currently taking corticosteroids
- Subjects with a known allergy to all contrast media available for use in HSG (Hysterosalpingogram)
- Subjects scheduled to undergo concomitant intrauterine procedures at the time of insert placement (e.g., endometrial ablation, fibroid resection by hysteroscopy, endometrial polypectomy). Intrauterine device removal is not considered a concomitant procedure.
- Subjects with any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy
- Subjects with a close affiliation with the investigational site, e.g. closely related or affiliated with the investigator (such as dependent, employee or student of the investigational site, or sponsor's staff)
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
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：ESS310
All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement
大体时间：Day 1
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Day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Successful bilateral placement rate of the ESS310 insert at first attempt in all subjects who undergo hysteroscopy with the intent of having bilateral ESS310 placement
大体时间：Day 1
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Day 1
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Evaluation of investigator questionnaire regarding ESS310 design and usability
大体时间：Day 1
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Potential aspects of the ESS310 design and usability that may impact bilateral placement rate at first attempt
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Day 1
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Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt
大体时间：Day 1
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Day 1
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Hysteroscopy time to perform the procedure
大体时间：Day 1
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Day 1
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Number of participants with Adverse device effects (ADE) as a measure of safety and tolerability
大体时间：1 week
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1 week
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Number of participants with Adverse procedure-related events as a measure of safety and tolerability
大体时间：Day 1, 1 week
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Day 1, 1 week
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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
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 (实际的)
2014年3月17日
初级完成 (实际的)
2014年10月2日
研究完成 (实际的)
2014年11月26日
研究注册日期
首次提交
2014年2月14日
首先提交符合 QC 标准的
2014年2月14日
首次发布 (估计)
2014年2月17日
研究记录更新
最后更新发布 (实际的)
2021年4月8日
上次提交的符合 QC 标准的更新
2021年4月6日
最后验证
2021年4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
- 17069
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.