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

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ClinicalTrials.gov Identifier: NCT00544310
Recruitment Status : Unknown
Verified August 2008 by OMRIX Biopharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2007
Last Update Posted : August 20, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Bilateral Ovarian Disease Biological: Anti adhesion agent Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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
Study Start Date : January 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Post surgery adhesion prevention treatment
Biological: Anti adhesion agent
Adhesions prevention
Other Name: Adhexil


Outcome Measures

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

Eligibility Criteria

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 Posted: October 16, 2007    Key Record Dates
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