Status:
SUSPENDED
Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery
Lead Sponsor:
OMRIX Biopharmaceuticals
Conditions:
Ovarian Cysts
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
Patients will be divided into two arms: 1) patients who will be treated in accordance with standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian tube.
Eligibility Criteria
Inclusion
- Female patients aged 18-45 years at screening.
- Patients undergoing elective laparoscopic surgery involving at least one adnexa.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00865488
Start Date
May 1 2009
End Date
April 1 2010
Last Update
December 23 2009
Active Locations (5)
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1
Richmond, Virginia, United States
2
Duisburg, Germany
3
Mexico City, Mexico
4
Moscow, Russia