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

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.

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