NCT05645809招募中不适用
A Multicenter, Randomized, Single-blinded, Active Controlled, Non-inferiority, Post Marketing Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2022年11月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Time used for suturing the surgical site during laparoscopic hysterectomy
研究概览
简要总结
Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for hysterectomy by laparoscopic surgery
- •Patients who are scheduled to undergo hysterectomy after being diagnosed with benign tumors in the uterus, including uterine myoma, according to the medical judgment of the investigator
- •Laparoscopic surgery includes general laparoscopic surgery and robotic surgery.)
排除标准
- •Patients with contaminated wounds
- •Diseases that may affect wound healing
- •When gynecological malignancy or intra-abdominal metastasis is confirmed at the time of enrollment
结局指标
主要结局
Time used for suturing the surgical site during laparoscopic hysterectomy
时间窗: 0Day
Time used from when the first suture is started to when the last suture is finished and the suture is cut
次要结局
未报告次要终点
研究者
研究点 (1)
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