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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598130
First Posted: January 18, 2008
Last Update Posted: November 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
OMRIX Biopharmaceuticals
  Purpose
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.

Condition Intervention Phase
Hemostatic Techniques Nephrectomy Biological: Fleece Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by OMRIX Biopharmaceuticals:

Primary Outcome Measures:
  • Proportion of successes at 10 minutes following randomization [ Time Frame: 10 minutes ]

Secondary Outcome Measures:
  • Proportion of successes at 5 minutes following randomization [ Time Frame: 5 minutes ]

Estimated Enrollment: 30
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
patients who will be treated in accordance with standard of care
Biological: Fleece
Fibrin Patch
Active Comparator: II
patients for which the Fibrin Fleece will be applied directly on the active bleeding site.
Biological: Fleece
Fibrin Patch

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598130


Locations
Israel
Bnei-Zion MC
Haifa, Israel
Meir MC
Kfar Saba, Israel
Rabin MC
Tel Aviv, Israel
Sheaba MC
Tel-Aviv, Israel
Sponsors and Collaborators
OMRIX Biopharmaceuticals
Investigators
Principal Investigator: Yoram Dekel, MD Rabin MC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eran Kurman - Clinical Affaires Manager, Omrix Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00598130     History of Changes
Other Study ID Numbers: FL-PN-002-IS
MoH
First Submitted: December 23, 2007
First Posted: January 18, 2008
Last Update Posted: November 6, 2009
Last Verified: November 2009

Keywords provided by OMRIX Biopharmaceuticals:
Patients undergoing elective open partial nephrectomy surgery
Excision of a kidney

Additional relevant MeSH terms:
Hemostatics
Coagulants