NCT01861886已完成不适用
A Multi-Centre Clinical Study to Evaluate the Safety and Effectiveness of the ESS505® Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception
Bayer5 个研究点 分布在 2 个国家目标入组 73 人开始时间: 2013年1月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 5
- 主要终点
- Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.
研究概览
简要总结
To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy.
详细描述
This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female with age range 21 to 44 years
- •Subjects who are seeking permanent contraception
- •Subjects with body weight within range of 40 - 136 kilograms (90-300 pounds)
- •Subjects willing to accept the risk of pregnancy occurring while relying solely on the ESS505 as contraception
- •Subjects for whom medical history and physical examination indicates bilateral viable and patent fallopian tubes
- •Subjects who are able to comply with the protocol required follow-up visits (e.g., 3 month clinic visit, and the 12-month telephone interview)
- •Subjects who provide written informed consent prior to enrolment
- •Subjects who have sufficient mental capability to provide clinically relevant and reliable feedback regarding her experience wearing the device
- •Subjects agrees that her anonymised personal data will be made available to Study sponsor, requisite regional and international regulatory bodies
- •Subjects for whom there are no contraindications for use as described in the ESS505 Instructions for Use (IFU)
排除标准
- •Subjects with known proximal tubal occlusion in either fallopian tube
- •Subjects who have undergone fallopian tube sterilization procedure
- •Subjects diagnosed with unicornuate uterus
- •Subjects diagnosed with endometrial or myometrial pathology which may prevent fallopian tube ostia assessment
- •Subjects scheduled to undergo concomitant intrauterine procedures at the time of ESS505 placement; IUD removal is not considered a concomitant procedure
- •Subjects suspected of being or confirmed pregnant
- •Subjects post-partum or has undergone pregnancy termination ≤6 weeks of scheduled ESS505 placement
- •Subjects diagnosed with active upper or lower pelvic infection
- •Subjects for whom there are one or more contraindications for use as described in the ESS505 IFU
- •Subjects have positive pre-procedure pregnancy test
研究组 & 干预措施
ESS505
Experimental
Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 in the proximal portion of the fallopian tubes using a transvaginal approach. Subsequent transvaginal ultrasound (TVU) or hysterosalpingogram (HSG) was performed approximately ≤ 3 hours and 90 days following insert placement.
干预措施: ESS505 (BAY1454033) (Device)
结局指标
主要结局
Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.
时间窗: 3 months
次要结局
- Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception(12 months)
- Frequency (number) of reported ESS505 placement procedure-related AEs(3 months)
- Severity of reported ESS505 placement procedure-related AEs(3 months)
- Frequency (number) of reported ESS505 (device) wearing-related AEs(3 months)
- Severity of reported ESS505 wearing-related AEs(3 months)
研究者
研究点 (5)
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