jRCT2072210100已完成不适用
An Open-label Study of SI-449 Resorbable Adhesion Barrier System in Patients Undergoing Laparoscopic Uterine Myomectomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age 0month 0week old over 至 No limit（—）
- 性别
- Female
入选标准
- •Subjects undergoing laparoscopic uterine myomectomy.
排除标准
- •Subjects with history of surgery in the abdominal or pelvic cavity.
- •Subjects with having active infection in the abdominal or pelvic cavity.
- •Subjects with history of hypersensitivity to the investigational device.
- •Subjects with a serious hepatic or a serious renal disorder.
- •Subjects who participated in another clinical study of any drug or medical device within 16 weeks prior to the day of informed consent.
结局指标
主要结局
-
Operability, safety
次要结局
未报告次要终点
研究者
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