Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil
This trial is active, not recruiting.
|Condition||bilateral ovarian disease|
|Treatment||anti adhesion agent|
|Phase||phase 1/phase 2|
|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|
|New York, NY||not available||no longer recruiting|
|Duisburg, Germany||not available||no longer recruiting|
|Valencia, Spain||not available||no longer recruiting|
|Oxford, United Kingdom||not available||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Post surgery adhesion prevention treatment
Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries
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.
|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.|
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