Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

A Prospective, Controlled, Randomized, Multi-Center, Exploratory Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

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.

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.

Inclusion Criteria:

• Female patients aged 18-45 years at screening
• Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease

Exclusion Criteria:

• 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.