Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery
NCT ID: NCT00865488
Last Updated: 2009-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
80 participants
INTERVENTIONAL
2009-05-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
patients who will be treated in accordance with standard of care
No interventions assigned to this group
2
patients for which Adhexil will be applied to prevent/reduce adhesions
ADHEXIL
Adhesions prevention
Interventions
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ADHEXIL
Adhesions prevention
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing elective laparoscopic surgery involving at least one adnexa.
Exclusion Criteria
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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OMRIX Biopharmaceuticals
INDUSTRY
Responsible Party
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Omrix Biopharmaceuticals Ltd.
Principal Investigators
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Eran Kurman, B.med.Sc, MBA
Role: STUDY_CHAIR
OMRIX Biopharmaceuticals
Locations
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Richmond, Virginia, United States
Duisburg, , Germany
Mexico City, , Mexico
Moscow, , Russia
Valencia, , Spain
Countries
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Other Identifiers
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AA-GYN-002
Identifier Type: -
Identifier Source: org_study_id