Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery

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

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.

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.

Inclusion Criteria:

• Female patients aged 18-45 years at screening.
• Patients undergoing elective laparoscopic surgery involving at least one adnexa.

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.