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

Omrix Biopharmaceuticals Ltd.0 个研究点目标入组 25 人开始时间: 2007年6月3日最近更新: 2019年12月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Omrix Biopharmaceuticals Ltd.
入组人数: 25

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 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.
•11.Investigator’s opinion that the patient is medically unfit or would be at major risk if enrolled into the study
•12.Patients with American Society of Anesthesiologists class > I
•Intra-Operative Exclusion Criteria
•1.Failure to lyse any of the existing ovarian adhesions
•2.Absence of one or both ovaries
•3.Absence of one or both Fallopian tubes
•4.Presence of active infection.
•5.Presence of malignancy
•6.Use of heparin-containing irrigants
•7.Use of other adjuvants for the purpose of reducing adhesions, including INTERCEED, SprayGel, Seprafilm, ADEPT, Hyskon, Oxiplex, corticosteroids, anticoagulants, and nonsteroidal anti-inflammatory agents.
•8.Requirement to perform enterotomy and/or cystotomy and/or urostomy and/or hysterectomy
•9.Patients who underwent a peritoneal grafting procedure
•10.Patients in whom a procedure required conversion to laparotomy
•11.Use of any topical hemostatic agents that are left behind in the body or use of catgut, chromic catgut, or nonresorbable sutures on the ovaries or immediately adjacent structures
•12.Use of gasless laparoscopy
•13.Performance of non-gynecologic surgical procedure (cholecystectomy)
•14.Investigator’s opinion that a second look is not in the best interest of the patient

研究者

发起方

Omrix Biopharmaceuticals Ltd.

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