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Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery

This study has suspended participant recruitment.
Sponsor:
Information provided by:
OMRIX Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00865488
First received: March 18, 2009
Last updated: December 20, 2009
Last verified: December 2009
History of Changes
  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 3

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:

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 of the Russian Federation
Spain: Ethics Committee
Spain: Ministry of Health
Mexico: Ministry of Health
Mexico: Ethics Committee

Additional relevant MeSH terms:
Ovarian Cysts
Cysts
Ovarian Diseases
Tissue Adhesions
Endometriosis
Cicatrix
Fibrosis
 Pathologic Processes
Genital Diseases, Female
Neoplasms
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013