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Sponsored by: |
OMRIX Biopharmaceuticals |
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Information provided by: | OMRIX Biopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00598130 |
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 |
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Hemostatic Techniques Nephrectomy |
Biological: Fleece |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Experimental
patients who will be treated in accordance with standard of care
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Biological: Fleece
Fibrin Patch
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II: Active Comparator
patients for which the Fibrin Fleece will be applied directly on the active bleeding site.
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Biological: Fleece
Fibrin Patch
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eran Kurman | +972 544984858 | eran@omrix.co.il |
Israel | |
Bnei-Zion MC | Recruiting |
Haifa, Israel | |
Sheaba MC | Not yet recruiting |
Tel-Aviv, Israel | |
Rabin MC | Active, not recruiting |
Tel Aviv, Israel | |
Meir MC | Not yet recruiting |
Kfar Saba, Israel |
Principal Investigator: | Yoram Dekel, MD | Rabin MC |
Responsible Party: | Omrix Biopharmaceuticals ( Eran Kurman - Clinical Affaires Manager ) |
Study ID Numbers: | FL-PN-002-IS, MoH |
Study First Received: | December 23, 2007 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00598130 History of Changes |
Health Authority: | Israel: Ministry of Health |
Patients undergoing elective open partial nephrectomy surgery Excision of a kidney |
Hemostatics |
Coagulants Therapeutic Uses Hematologic Agents Pharmacologic Actions Hemostatics |