NCT02097446Unknown3 期
Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy : A Prospective, Randomized, Controlled Study
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Anti-Adhesion Rate
研究概览
简要总结
- Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous cystadenoma)
- Intervention: Device ( Test group : Guardix-FL, Control group : Interceed)
- Primary Outcome Measure : Anti-adhesion Rate
- Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patients who sign the written informed consent
- •Women aged between 18 and 44
- •The patients who are able to participate in clinical trial during the period of study
- •The patients without abnormal figures at the screening laboratory examination
- •The patients expecting ovarian cystectomy for benign ovarian tumor(mature cystic teratoma, Mucinous cystadenoma, serous cystadenoma)
排除标准
- •The patients who took treatments with medical products which might be barrier to evaluate the effectiveness
- •The patients who took medicine like other anti-adhesion, absorbable hemostat and dose of steroid, immunosuppressants
- •The patients with severe drug allergy
- •The patients with infectious disease on abdominal or pelvic cavity
- •The patients who previously participated in another clinical trials within the past 30 days
- •The patients considered inappropriate for the study
- •The pregnant
- •The patients with severe renal disease
- •The patients with severe systemic diseases
结局指标
主要结局
Anti-Adhesion Rate
时间窗: Post-Operative Day+4weeks(Second - look)
Adhesion yes or no
次要结局
- Score(Post-Operative Day+4weeks(Second-look))
研究者
研究点 (2)
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