Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil - Full Text View

Sponsored by:	OMRIX Biopharmaceuticals
Information provided by:	OMRIX Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00544310

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 I Phase II

MedlinePlus related topics: Adhesions

U.S. FDA Resources

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

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
1: Experimental Post surgery adhesion prevention treatment	Biological: Anti adhesion agent Adhesions prevention

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

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

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

Study placed in the following topic categories:

Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Endocrinopathy
Ovarian Diseases

Additional relevant MeSH terms:

Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009