NCT01637974Unknown不适用
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery - a Prospective Double Blind Randomized Study
Carmel Medical Center1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy
研究概览
简要总结
The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.
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, Care Provider)
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
- •Age between 18 and 50 years
- •Must be able to understand, read and sign consent form
排除标准
- •Signs of infection upon admission
- •Ongoing pregnancy
- •Carcinoma of the uterus or cervix
- •Recurrent PID
- •Women admitted for endometrial ablation
- •Women that gave birth 6 weeks ago
- •Women participating in another study
研究组 & 干预措施
with INTERCOAT
Experimental
injection of intercoat into the euterine cavity at the end of hysteroscopy
干预措施: INTERCOAT administration (Drug)
结局指标
主要结局
Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy
时间窗: one year
次要结局
未报告次要终点
研究者
Moran Paz
M.D.
Carmel Medical Center
研究点 (1)
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