NCT00420264已完成不适用
Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation
Female Pelvic Medicine & Urogynecology Institute of Michigan2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2005年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Tolerability of Uterine Ablation in the office setting
研究概览
简要总结
Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can be tolerated in the office setting without the use of intravenous medication.
详细描述
A safe and effective treatment , called endometrial ablation, has been used in a hospital setting under general anesthesia for the treatment of heavy uterine bleeding. This study will evaluate if patients would tolerate the same procedure in an office setting using local anesthetics and common pain medication. This study will include twenty patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Heavy uterine bleeding
排除标准
- •Uterine or cervical cancer
- •Unable to tolerate office hysteroscopy
- •Uterine fibroid tumors that distort endometrial cavity
- •Uterine cavity greater than 12 cm
- •Patients with hyperplasia or premalignant changes of the endometrium
- •Active genital or urinary tract infections
- •Intrauterine device
- •Pregnant or want to become pregnant
结局指标
主要结局
Tolerability of Uterine Ablation in the office setting
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (2)
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