NL-OMON49341已完成不适用
PREvention of intrauterine adhesion after hysteroscopic surgery with novel deGradable film - PREG1
WOMED0 个研究点目标入组 12 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
- 12
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
- •* Women * 40 years AND no childbearing wish until the second look hysteroscopy,
- •OR history of permanent sterilization;
- •* Subject scheduled for myomectomy for one or more myoma(s) where one myoma is
- •at least 10mm in size (*10mm) as estimated by pre-operative ultrasound
- •measurement of the largest diameter
- •* Hysterometry prior to device insertion * 6cm and * 9cm.
- •* Subjects who are willing to provide a written informed consent as approved by
- •the applicable Ethics Committee prior to participating in this clinical
- •investigation.
- •* Subjects who can comply with the study follow-up or other study requirements
排除标准
- •* Current pregnancy
- •* Abnormal uterine cavity
- •* Known or suspected endometrial hyperplasia
- •* Medical history of cervical or endometrial cancer
研究者
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