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

Phase 1

• Conditions: Bilateral Ovarian Disease
• Interventions: Biological: Anti adhesion agent

• Registration Number: NCT00544310
• Lead Sponsor: OMRIX Biopharmaceuticals

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-10-15
• Study First Submitted QC: 2007-10-15
• Study First Posted: 2007-10-16
• Study Start: 2008-01
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-19
• Last Update Posted: 2008-08-20
• Study Completion: 2008-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Anti adhesion agent	Post surgery adhesion prevention treatment

Primary Outcome Measures

Name	Time	Method
Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries