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.

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Key information

Conditions

Hemostatic Techniques Nephrectomy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bnei-Zion MC, Haifa, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fleece

Biological

Fibrin Patch

Primary outcomes

Proportion of successes at 10 minutes following randomization

Time frame: 10 minutes

Secondary outcomes

Proportion of successes at 5 minutes following randomization

Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

OMRIX Biopharmaceuticals

Industry

Registry information

Official study 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

Acronym: Fleece

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2009
First posted: Jan 18, 2008
Registry last updated: Nov 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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