NCT00598130

Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: OMRIX Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemostatic Techniques
• Nephrectomy

Interventions

Type	Name	Description
BIOLOGICAL	Fleece	Fibrin Patch

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-11-01
• Completion: 2009-02-01
• First posted: 2008-01-18
• Last updated: 2009-11-06

Locations

4 sites across 1 country: Israel