NCT04007211已完成不适用
A Randomized, Multi-center, Evaluator and Subject Blind, Active-controlled, Parallel, Medical Device Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Compared to Hyalobarrier Applied to Postoperative Intrauterine
Medy-Tox2 个研究点 分布在 2 个国家目标入组 192 人开始时间: 2017年2月27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
- 192
- 试验地点
- 2
- 主要终点
- Incidence of intrauterine adhesion
研究概览
简要总结
This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged from 19 to 70
- •Those who are scheduled for hysteroscopy to treat the following diseases: submucosal myomas, endometrial polyps, intrauterine adhesion etc.
排除标准
- •Those who will apply other intrauterine device rather than investigational device during the study period.
结局指标
主要结局
Incidence of intrauterine adhesion
时间窗: 4 weeks
Incidence rate of intrauterine adhesion after surgery
次要结局
未报告次要终点
研究者
研究点 (2)
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