Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery - Full Text View

Sponsor:	OMRIX Biopharmaceuticals
Information provided by:	OMRIX Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00865488

Purpose

The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.

Condition	Intervention	Phase
Ovarian Cysts Endometriosis Adhesions	Biological: ADHEXIL	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Prospective, Controlled, Randomized, Multi-Center, Pivotal Study Evaluating the Safety and Efficacy of AdhexilTM in Prevention And/Or Reduction of Adhesions in Gynecology Surgery

Resource links provided by NLM:

MedlinePlus related topics: Adhesions Endometriosis Ovarian Cysts

U.S. FDA Resources

Further study details as provided by OMRIX Biopharmaceuticals:

Primary Outcome Measures:

Adhesions will be assessed according to incidence, extent and severity. [ Time Frame: 8 weeks post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	May 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 patients who will be treated in accordance with standard of care
Experimental: 2 patients for which Adhexil will be applied to prevent/reduce adhesions	Biological: ADHEXIL Adhesions prevention

Detailed Description:

Patients will be divided into two arms: 1) patients who will be treated in accordance with standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian tube.

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 involving at least one adnexa.

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: NCT00865488

Locations

United States, Virginia

Richmond, Virginia, United States
Germany

Duisburg, Germany
Mexico

Mexico City, Mexico
Russian Federation

Moscow, Russian Federation
Spain

Valencia, Spain

Sponsors and Collaborators

OMRIX Biopharmaceuticals

Investigators

Study Chair:

Eran Kurman, B.med.Sc, MBA

OMRIX Biopharmaceuticals

More Information

No publications provided

Responsible Party:	Eran Kurman, Clinical Affairs Manager, Omrix Biopharmaceuticals Ltd.
ClinicalTrials.gov Identifier:	NCT00865488 History of Changes
Other Study ID Numbers:	AA-GYN-002
Study First Received:	March 18, 2009
Last Updated:	December 20, 2009
Health Authority:	United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institut; Germany: Ethics Commission; Russia: Ministry of Health and Social Development of the Russian Federation; Spain: Ethics Committee; Spain: Ministry of Health; Mexico: Ministry of Health; Mexico: Ethics Committee

Additional relevant MeSH terms:

Tissue Adhesions
Endometriosis
Ovarian Cysts
Cicatrix
Fibrosis
Pathologic Processes
Genital Diseases, Female

Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012