NCT00544310Unknown1 期
A Prospective, Controlled, Randomized, Multi-Center, Exploratory Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries
研究概览
简要总结
The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA) kit, Adhexil™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.
详细描述
Adhexil™ contains the components that form the anti-adhesive barrier, BAC and Thrombin. Thrombin is a sterile solution, containing highly purified human thrombin. BAC is a sterile, solution whose principal component is a concentrate of human fibrinogen. Adhexil™ is supplied in two vials and an application device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-45 years at screening
- •Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease
排除标准
- •Pregnant (including ectopic pregnancy) or breastfeeding patient
- •Patients with a documented diagnosis of cancer
- •Patients with a lymphatic, hematologic or coagulation disorder
- •Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™
- •Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.
- •Patients who have participated in another clinical study within 30 days of enrolment.
- •Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.
研究组 & 干预措施
1
Experimental
Post surgery adhesion prevention treatment
干预措施: Anti adhesion agent (Biological)
结局指标
主要结局
Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries
次要结局
未报告次要终点
研究者
研究点 (4)
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