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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Bilateral Ovarian Disease

In brief

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.

Key facts

Study ID

NCT00544310

Run by

OMRIX Biopharmaceuticals

People needed

25

Starts

2008-01-01

Expected to finish

2008-10-01

Last updated by the study team

2008-08-20

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients aged 18-45 years at screening
• Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease

You may not qualify if…

• 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.

Where it is running

• Study site — New York, New York, United States
• Study site — Duisburg, Germany
• Study site — Valencia, Spain
• Study site — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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