NCT00865488暂停3 期
A Prospective, Controlled, Randomized, Multi-Center, Pivotal Study Evaluating the Safety and Efficacy of AdhexilTM in Prevention And/Or Reduction of Adhesions in Gynecology Surgery
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Adhesions will be assessed according to incidence, extent and severity.
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.
详细描述
Patients will be divided into two arms: 1) patients who will be treated in accordance with standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian tube.
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
- 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 involving at least one adnexa.
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
No Intervention
patients who will be treated in accordance with standard of care
2
Experimental
patients for which Adhexil will be applied to prevent/reduce adhesions
干预措施: ADHEXIL (Biological)
结局指标
主要结局
Adhesions will be assessed according to incidence, extent and severity.
时间窗: 8 weeks post surgery
次要结局
未报告次要终点
研究者
研究点 (5)
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