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
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.
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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