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

This study has suspended participant recruitment.
ClinicalTrials.gov Identifier:
First Posted: March 19, 2009
Last Update Posted: December 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
OMRIX Biopharmaceuticals
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.

Condition Intervention Phase
Ovarian Cysts Endometriosis Adhesions Biological: ADHEXIL Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective, Controlled, Randomized, Multi-Center, Pivotal Study Evaluating the Safety and Efficacy of AdhexilTM in Prevention And/Or Reduction of Adhesions in Gynecology Surgery

Resource links provided by NLM:

Further study details as provided by OMRIX Biopharmaceuticals:

Primary Outcome Measures:
  • Adhesions will be assessed according to incidence, extent and severity. [ Time Frame: 8 weeks post surgery ]

Estimated Enrollment: 80
Study Start Date: May 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
patients who will be treated in accordance with standard of care
Experimental: 2
patients for which Adhexil will be applied to prevent/reduce adhesions
Biological: ADHEXIL
Adhesions prevention

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female patients aged 18-45 years at screening.
  • Patients undergoing elective laparoscopic surgery involving at least one adnexa.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865488

United States, Virginia
Richmond, Virginia, United States
Duisburg, Germany
Mexico City, Mexico
Russian Federation
Moscow, Russian Federation
Valencia, Spain
Sponsors and Collaborators
OMRIX Biopharmaceuticals
Study Chair: Eran Kurman, B.med.Sc, MBA OMRIX Biopharmaceuticals
  More Information

Responsible Party: Eran Kurman, Clinical Affairs Manager, Omrix Biopharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00865488     History of Changes
Other Study ID Numbers: AA-GYN-002
First Submitted: March 18, 2009
First Posted: March 19, 2009
Last Update Posted: December 23, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Ovarian Cysts
Ovarian Diseases
Tissue Adhesions
Genital Diseases, Female
Pathologic Processes
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases