Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy (Fleece)

November 5, 2009 updated by: OMRIX Biopharmaceuticals

A Prospective, Randomized, Single-Blind, Standard Care Controlled, Multi-Center, Phase II Study Evaluating the Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

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

      • Haifa, Israel
        • Bnei-Zion MC
      • Kfar Saba, Israel
        • Meir MC
      • Tel Aviv, Israel
        • Rabin MC
      • Tel-Aviv, Israel
        • Sheaba MC

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing elective open partial nephrectomy
  • Patients must be willing to participate in the study, and provide written informed consent

Exclusion Criteria:

  • Patients with a tumor diameter greater than 4 cm
  • Any additional surgical intervention other than partial nephrectomy
  • Patients with only one functional kidney
  • Patients with known intolerance to blood products or other components of the product

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I
patients who will be treated in accordance with standard of care
Fibrin Patch
Active Comparator: II
patients for which the Fibrin Fleece will be applied directly on the active bleeding site.
Fibrin Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of successes at 10 minutes following randomization
Time Frame: 10 minutes
10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of successes at 5 minutes following randomization
Time Frame: 5 minutes
5 minutes

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Yoram Dekel, MD, Rabin MC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

February 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

December 23, 2007

First Submitted That Met QC Criteria

January 17, 2008

First Posted (Estimate)

January 18, 2008

Study Record Updates

Last Update Posted (Estimate)

November 6, 2009

Last Update Submitted That Met QC Criteria

November 5, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

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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