NCT02957500Unknown不适用
To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Intrauterine Surgery in Patient With Gynecological Disease, a Multicenter, Randomized, Double- Blinded Study
CGBio Inc.1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2016年11月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Adhesion incidence rate following 4 weeks
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.
详细描述
to evaluate the efficacy and safety of Mediclore®, as an antiadhesive 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
- Double (Participant, Outcomes Assessor)
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
- •the patients with submucosal myomas, endometrial polyps, intra-uterine adhesion, uterine septa, dysfunctional uterine bleeding
- •Written informed consent
- •Patients without clinically significant lab
排除标准
- •having enrolled another clinical trials within 1 month
- •Immunosuppression or autoimmune disease
- •Anticoagulant, general steroids within a week from surgery
- •Incompatible medications
- •Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
结局指标
主要结局
Adhesion incidence rate following 4 weeks
时间窗: 4weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)Gynecologic DiseaseNCT03007654Yong Sang Song192
尚未招募
4 期
The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary StudyLumbar Disc DiseaseEpidural FibrosisFailed Back Surgery SyndromeNCT06034041King Chulalongkorn Memorial Hospital78
已完成
2 期
Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal AdhesionsIntraperitoneal AdhesionsNCT00512356Baxter Healthcare Corporation46
Unknown
不适用
Clinical Study on a Novel Anti-adhesion Barrier FilmIntrauterine AdhesionNCT05888545The Fourth Affiliated Hospital of Zhejiang University School of Medicine1,176
进行中（未招募）
不适用
Compont - Varicose Veins of the Lower ExtremitiesVaricose Veins of Lower LimbNCT06387264Peking University People's Hospital188