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Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by OMRIX Biopharmaceuticals.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00544310
First Posted: October 16, 2007
Last Update Posted: August 20, 2008
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
  Purpose
The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA) kit, Adhexil™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.

Condition Intervention Phase
Bilateral Ovarian Disease Biological: Anti adhesion agent Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Prospective, Controlled, Randomized, Multi-Center, Exploratory Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

Resource links provided by NLM:


Further study details as provided by OMRIX Biopharmaceuticals:

Primary Outcome Measures:
  • Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries

Estimated Enrollment: 25
Study Start Date: January 2008
Estimated Study Completion Date: October 2008
Arms Assigned Interventions
Experimental: 1
Post surgery adhesion prevention treatment
Biological: Anti adhesion agent
Adhesions prevention
Other Name: Adhexil

Detailed Description:
Adhexil™ contains the components that form the anti-adhesive barrier, BAC and Thrombin. Thrombin is a sterile solution, containing highly purified human thrombin. BAC is a sterile, solution whose principal component is a concentrate of human fibrinogen. Adhexil™ is supplied in two vials and an application device.
  Eligibility

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
Criteria

Inclusion Criteria:

  • Female patients aged 18-45 years at screening
  • Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease

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): NCT00544310


Locations
United States, New York
New York, New York, United States
Germany
Duisburg, Germany
Spain
Valencia, Spain
United Kingdom
Oxford, United Kingdom
Sponsors and Collaborators
OMRIX Biopharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00544310     History of Changes
Other Study ID Numbers: AA-GYN-001
First Submitted: October 15, 2007
First Posted: October 16, 2007
Last Update Posted: August 20, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases