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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by OMRIX Biopharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
OMRIX Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00544310
First received: October 15, 2007
Last updated: August 19, 2008
Last verified: August 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00544310     History of Changes
Other Study ID Numbers: AA-GYN-001
Study First Received: October 15, 2007
Last Updated: August 19, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014