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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.
Information provided by:
OMRIX Biopharmaceuticals Identifier:
First received: March 18, 2009
Last updated: December 20, 2009
Last verified: December 2009
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:

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 ]

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.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00865488

United States, Virginia
Richmond, Virginia, United States
Duisburg, Germany
Mexico City, Mexico
Russian Federation
Moscow, Russian Federation
Valencia, Spain
Sponsors and Collaborators
OMRIX Biopharmaceuticals
Study Chair: Eran Kurman,, MBA OMRIX Biopharmaceuticals
  More Information

Responsible Party: Eran Kurman, Clinical Affairs Manager, Omrix Biopharmaceuticals Ltd. Identifier: NCT00865488     History of Changes
Other Study ID Numbers: AA-GYN-002
Study First Received: March 18, 2009
Last Updated: December 20, 2009

Additional relevant MeSH terms:
Ovarian Cysts
Ovarian Diseases
Tissue Adhesions
Genital Diseases, Female
Pathologic Processes
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases processed this record on September 21, 2017