NCT02510443已完成不适用
Survey on Use and Characteristics of Definitive Contraception With ESsure®
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,644
- 主要终点
- Number of patients being satisfied with successful Essure procedure having no complications at 5 years
研究概览
简要总结
Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on patients.
详细描述
The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman ≥ 18 years old,
- •Scheduled for Essure procedure
- •Patient who has been given appropriate information about the study objectives and procedures and who has given her consent.
排除标准
- •Patients with contraindications as listed in the current Instruction For Use (IFU) will be excluded.
结局指标
主要结局
Number of patients being satisfied with successful Essure procedure having no complications at 5 years
时间窗: At 5 years
Patient satisfaction will be assessed on a Likert scale. Complications are migration/expulsion of Essure, infection. Pregnancy will be measured at any time Point.
次要结局
- Number of patients with moderate or important pain when placement is performed(At initial visit)
- Number of examinations by patients(At 3 months)
- Type of examinations by patients(At 3 months)
- Number of satisfied patients at 3, 12 and 24 months(At 3 ,12 and 24 months)
- Causes of unsatisfied patients(Up to 5 years)
- Number of patients with regrets(At 12 months, 24 months and 5 years)
- Number of unsatisfied patients(Up to 5 years)
- Number of good insert position by implant and patients with success in final result of the procedure(At 3 months)
研究者
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