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

NCT ID: NCT00544310

Last Updated: 2008-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bilateral Ovarian Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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1

Post surgery adhesion prevention treatment

Group Type EXPERIMENTAL

Anti adhesion agent

Intervention Type BIOLOGICAL

Adhesions prevention

Interventions

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Anti adhesion agent

Adhesions prevention

Intervention Type BIOLOGICAL

Other Intervention Names

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Adhexil

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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OMRIX Biopharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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New York, New York, United States

Site Status

Duisburg, , Germany

Site Status

Valencia, , Spain

Site Status

Oxford, , United Kingdom

Site Status

Countries

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United States Germany Spain United Kingdom

Other Identifiers

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AA-GYN-001

Identifier Type: -

Identifier Source: org_study_id