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

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ClinicalTrials.gov Identifier: NCT00598130
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : November 6, 2009
Sponsor:
Information provided by:
OMRIX Biopharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Hemostatic Techniques Nephrectomy Biological: Fleece Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : February 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : February 2009

Arm Intervention/treatment
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




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

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


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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

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 Posted: January 18, 2008    Key Record Dates
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