A Multi-Center, Multi-National Clinical Study to Evaluate the Safety and Effectiveness of the Essure® (Model ESS505) Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 660
- 试验地点
- 22
- 主要终点
- Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception
研究概览
简要总结
The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.
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, 21 to 44 years of age, inclusive
- •Body weight within range of 90-300 lbs (40 - 136 kg)
- •Sexually active (minimum of 4 coital acts per cycle)
- •Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
- •Medical history indicates bilateral viable and patent fallopian tubes
- •Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods
排除标准
- •Post-menopausal woman
- •Suspected or confirmed pregnancy
- •Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
- •Past fallopian tube sterilization procedure and/or total or partial salpingectomies
- •Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy
- •Currently taking corticosteroids
- •Known allergy to all contrast media available for use in hysterosalpingogram
- •Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
- •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
结局指标
主要结局
Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception
时间窗: 1 year
Evaluated after 6000 women-months of reliance have been accumulated
Reliance rate, defined as number of subjects told to rely on ESS505 after the Essure confirmation test divided by the number of subjects who had insert placement attempted
时间窗: 3 months
Evaluated after 3000 women-months of reliance have been accumulated (expected at the same time most subjects with implants have completed their 3 month follow-up visit)
次要结局
- Safety of subsequent wearing of the insert defined as number of subjects who experience an AE assessed as related to wearing of ESS505 divided by the number of subjects in whom the presence of an AE could be assessed(Up to 10 years)
- Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception(10 years)
- Safety of the ESS505 placement procedure defined as number of subjects who experience an AE assessed as related to the ESS505 placement procedure divided by the number of subjects in who at least one ESS505 was introduced into the fallopian tube(On day of placement procedure)