A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Sites Adherent to the Uterus
研究概览
简要总结
This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females, 18 years of age or older, of child-bearing potential.
- •Subject has at least one myoma >= 3 cm.
排除标准
- •Pregnant or lactating females.
- •Females undergoing prior open or closed myomectomy for treatment of myomas.
- •Evidence of current active endometriosis or infection
- •History of or active inflammatory bowel disease or pelvic inflammatory disease.
- •Presence of a frozen pelvis, or hydrosalpinges.
研究组 & 干预措施
Control
No adhesion barrier administered.
SprayShield™
SprayShield™
干预措施: SprayShield™ (Device)
结局指标
主要结局
Number of Sites Adherent to the Uterus
时间窗: 8-12 weeks post myomectomy
The number of times an adhesion is attached to the uterus.
Area of Sites Adherent to the Uterus (cm^2)
时间窗: 8-12 weeks post myomectomy
Mean Severity Score of Sites Adherent to the Uterus
时间窗: 8-12 weeks post myomectomy
The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.
Mean Extent Score of Sites Adherent to the Uterus
时间窗: 8-12 weeks post myomectomy
0 =no adhesions, 1=covering \<25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering \>51% of locations' total area.
次要结局
未报告次要终点