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NCT00598130 Clinical Trial

Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

Nephrectomy Clinical Trial

— Fleece  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00598130
Other study ID # FL-PN-002-IS
Secondary ID MoH
Status Completed
Phase Phase 2
First received December 23, 2007
Last updated November 5, 2009
Start date February 2008
Est. completion date February 2009

Study information
Verified date November 2009
Source OMRIX Biopharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date February 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Fleece
Fibrin Patch

Locations
Country Name City State
Israel Bnei-Zion MC Haifa
Israel Meir MC Kfar Saba
Israel Rabin MC Tel Aviv
Israel Sheaba MC Tel-Aviv

Sponsors (1)
Lead Sponsor Collaborator
OMRIX Biopharmaceuticals

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of successes at 10 minutes following randomization 10 minutes No
Secondary Proportion of successes at 5 minutes following randomization 5 minutes No
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