NL-OMON39616
已完成
2 期
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 - ESS505-003 Study
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Women ages range 21 to 44 years desiring permanent contraception
- 发起方
- Bayer
- 入组人数
- 40
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Females with age range 21 to 44 years;
- •2\. Subjects seeking permanent contraception;
- •3\. Subjects with body weight within range of 40 \- 136 kilograms (90\-300 pounds);
- •4\. Subjects willing to accept the risk of pregnancy occurring whilst relying solely on the ESS505 for contraception;
- •5\. Subjects for whom medical physical history indicate bilateral viable and patent fallopian tubes;
- •6\. Subjects are able to comply with the protocol required follow\-up visits (e.g., 3\-month clinic visit, and the 12\-month telephone interview);
- •7\. Subjects provide written informed consent prior to enrolment;
- •8\. Subjects who have sufficient mental capability to provide clinically relevant and reliable feedback regarding their experience wearing the device;
- •9\. Subjects who agree that anonymised personal data will be made available to Study sponsor, requisite regional and international regulatory bodies;
- •10\. Subjects have no contraindications for use as described in the ESS505 Instructions for Use (\*IFU\*), i.e. women with bilateral proximal tubal occlusion, women who have undergone fallopian tube sterilization, women with known endometrial or myometrial pathology which is likely to prevent access to the fallopian tube ostia, women who are post\-menopausal, women with pelvic inflammatory disease, women who are pregnant or may become pregnant, women wih gynecologic malignancy, women with a general systemic disease or condition that could represent a risk, women who deliveres or terminated a pregnancy less than 6 weeks before Essure insert placement, women with a known allergy to contrast media, women with any general health condition that may represent, in the opinion of the physician, an increased potential risk associated with device use.
排除标准
- •1\. Subjects with known proximal tubal occlusion in either fallopian tube;
- •2\. Subjects who has undergone fallopian tube sterilisation procedure;
- •3\. Subjects diagnosed with unicornuate uterus;
- •4\. Subjects diagnosed with endometrial or myometrial pathology which may prevent fallopian tube ostia assess;
- •5\. Subjects scheduled to undergo concomitant intrauterine procedures at the time of ESS505 placement; IUD removal is not considered a concomitant procedure. ;6\. Subjects suspected of being or confirmed pregnant;
- •7\. Subjects post\-partum or undergone pregnancy termination \<\=6 weeks of scheduled ESS505 placement;
- •8\. Subjects diagnosed with upper or lower pelvic infection;
- •9\. Subjects for whom there are one or more contraindications for use as described in the ESS505 IFU;
- •10\. Subjects with positive pre\-procedure pregnancy test.
结局指标
主要结局
未指定
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