This trial is active, not recruiting.

Condition bilateral ovarian disease
Treatment anti adhesion agent
Phase phase 1/phase 2
Sponsor OMRIX Biopharmaceuticals
Start date January 2008
End date October 2008
Trial size 25 participants
Trial identifier NCT00544310, AA-GYN-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double-blind
Primary purpose prevention
Post surgery adhesion prevention treatment
anti adhesion agent Adhexil
Adhesions prevention

Primary Outcomes

Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries
time frame:

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.

Additional Information

Official title A Prospective, Controlled, Randomized, Multi-Center, Exploratory Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2008.
Information provided to ClinicalTrials.gov by OMRIX Biopharmaceuticals.