EUCTR2007-001326-26-GB
进行中（未招募）
1 期
A Prospective, Controlled, Randomized, Multi-Center, Phase I/II Study Evaluating the Safety and Efficacy of Adhexil™ - Using Adhexil To Prevent and/or Reduce Adhesions After Ovarian Surgery
适应症Patients that undergo surgery that involves the ovariesMedDRA version: 9.1 Level: PT Classification code 10033137 Term: Ovarian cystectomy
相关药物Quixil
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Patients that undergo surgery that involves the ovaries
- 发起方
- Omrix Biopharmaceuticals Ltd.
- 入组人数
- 25
- 状态
- 进行中（未招募）
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Female patients aged 18\-45 years at screening
- •2\.Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease
- •3\.Patients must be willing to participate in the study, and provide written informed consent
- •4\.Patient available and willing to undertake study visits and procedures
- •5\.Patients of child\-bearing potential must be using a medically acceptable method of birth control throughout the study.
- •6\.Presence of both ovaries and both intact fallopian tubes.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
排除标准
- •1\.Pregnant (including ectopic pregnancy) or breastfeeding patients
- •2\.Patients whose 1LL procedure would involve enterotomy and/or cystotomy and/or urostomy, and/or postoperative hydrotubation
- •3\.Patients whose 1LL procedure would involve surgical sterilization
- •4\.Patients whose 1LL procedure would involve hysterectomy
- •5\.Patients with a documented diagnosis of cancer
- •6\.Patients with a lymphatic, hematologic or coagulation disorder
- •7\.Known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™
- •8\.Patients whose pre\-operative laboratory values at the baseline visit are out of normal ranges
- •9\.Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.
- •10\.Patients who have participated in another clinical study within 30 days of enrolment.
结局指标
主要结局
未指定
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