NL-OMON31767已完成不适用
HYSTEROSCOPIC CRYOMYOLYSIS FOR THE TREATMENT OF SUBMUCOSAL LEIOMYOMATA - HCT
Galil Medical0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Primary complaint is excessive bleeding
- •* Subject is able to understand and give informed consent for participation in the study
- •* Pre-menopausal woman between the ages of 30 and 50 (inclusive)
- •* Has completed childbearing and not contemplating future fertility
- •* Has symptomatic uterine fibroids
- •o Symptomatic subjects defined as
- •* Abnormal uterine bleeding
- •* Either menorrhagia or metrorrhagia, or menometrorrhagia (with no infectious or pre-malignant/malignant cause of bleeding)
- •* Socially disruptive bleeding
- •* Bleeding defined as bothersome to the patient that interferes with daily activities
- •* Fibroids type, size, location and number
- •o 1 submucosal fibroid
- •o Type I and Type II fibroids
- •* Using contraception to prevent pregnancy
排除标准
- •* Any evidence of known or suspected infection or pre-malignancy/malignancy
- •* Desire for future child bearing
- •* Use of GnRH analogues within 3 months prior to cryotherapy treatment
- •* Fibroids
- •o Size > 4 cm
- •o 2 or more submucosal fibroids
- •o Fibroid distance from serosa is less than 1 cm
研究者
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