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

December 20, 2009 updated by: OMRIX Biopharmaceuticals

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adhesions will be assessed according to incidence, extent and severity.
Time Frame: 8 weeks post surgery
8 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OMRIX Biopharmaceuticals

Investigators

  • Study Chair: Eran Kurman, B.med.Sc, MBA, Omrix Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

March 18, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Estimate)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 20, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA-GYN-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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