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

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. Identifier: NCT00865488
Recruitment Status : Suspended
First Posted : March 19, 2009
Last Update Posted : December 23, 2009
Information provided by:
OMRIX Biopharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Ovarian Cysts Endometriosis Adhesions Biological: ADHEXIL Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Study Start Date : May 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT00865488

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

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Responsible Party: Eran Kurman, Clinical Affairs Manager, Omrix Biopharmaceuticals Ltd. Identifier: NCT00865488    
Other Study ID Numbers: AA-GYN-002
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Ovarian Cysts
Tissue Adhesions
Genital Diseases, Female
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases