Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery

Paused · Phase 3

Conditions studied: Ovarian Cysts, Endometriosis, Adhesions

In brief

The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.

Key facts

Study ID

NCT00865488

Run by

OMRIX Biopharmaceuticals

People needed

80

Starts

2009-05-01

Expected to finish

2010-04-01

Last updated by the study team

2009-12-23

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 involving at least one adnexa.

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 — Richmond, Virginia, United States
• Study site — Duisburg, Germany
• Study site — Mexico City, Mexico
• Study site — Moscow, Russia
• Study site — Valencia, Spain

Full record on ClinicalTrials.gov

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