A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 3
- 主要终点
- The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage.
研究概览
简要总结
The purpose of this research study is to obtain preliminary data of the safety and effectiveness of Sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion prevention barrier after laparoscopic myomectomy versus no adhesion barrier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and SLL.
排除标准
- •Pregnant/lactating women.
- •The patient has a history of hypersensitivity to exogenous carboxymethylcellulose products and/or hyaluronic acid.
- •The patient's procedure resulted in entry of the endometrial cavity, or entry of the bowel including appendectomy.
结局指标
主要结局
The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage.
时间窗: 30 Days post surgery
Efficacy endpoints are on adhesion formation and will include the success the success criterion for the individual patients as either anterior or posterior uterus free of dense adhesions.
时间窗: Until end of study
次要结局
未报告次要终点