Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

August 19, 2008 updated by: OMRIX Biopharmaceuticals

A Prospective, Controlled, Randomized, Multi-Center, Exploratory Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

25

Phase

  • Phase 2
  • Phase 1

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 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.

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Post surgery adhesion prevention treatment
Biological: Anti adhesion agent
Adhesions prevention
Other Names:
  • Adhexil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries

Collaborators and Investigators

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

Sponsor

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

January 1, 2008

Study Completion (Anticipated)

October 1, 2008

Study Registration Dates

First Submitted

October 15, 2007

First Submitted That Met QC Criteria

October 15, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

August 20, 2008

Last Update Submitted That Met QC Criteria

August 19, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA-GYN-001

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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