NCT01979861Unknown3 期
A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding
Aegea Medical, Inc.29 个研究点 分布在 4 个国家目标入组 230 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 230
- 试验地点
- 29
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)
详细描述
This is a single-arm, multi-center study with three years of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subject from (and including) age 30 to 50 years
- •Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months
- •Predictable cyclic menstrual cycles over past 6 months
- •Excessive uterine bleeding
- •Premenopausal at enrollment
- •Normal PAP
- •Normal endometrial biopsy
- •Willing to use reliable contraception
- •Not currently taking hormonal medication
- •Agree to use sponsor provided catamenial product (sanitary pads/tampons)
排除标准
- •Desires future childbearing
- •Presence of an IUD
- •Previous endometrial ablation procedure
- •Evidence of STI
- •Evidence of PID
- •Active infection of genitals, vagina, cervix, uterus or urinary tract
- •Active endometritis
- •Active bacteremia, sepsis or other active systemic infection
- •Gynecologic malignancy
- •Endometrial hyperplasia
- •Known clotting defects or bleeding disorders
- •On anticoagulant therapy
- •Hemoglobin <8gm/dl
- •Prior uterine surgery
- •Currently on medication that could thin myometrial muscle
- •Severe dysmenorrhea, secondary to adenomyosis
- •Abnormal uterine cavity
- •Hydrosalpinx
- •Uterine length <6cm or >12cm
- •Currently in other clinical trial
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 12 months
Reduction of menstrual blood loss
次要结局
- Secondary Effectiveness Endpoint(12 months)
研究者
研究点 (29)
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