Expired Study
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New York, New York


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00544310


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

New York, New York
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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