- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00598130
Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy (Fleece)
November 5, 2009 updated by: OMRIX Biopharmaceuticals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel
- Bnei-Zion MC
-
Kfar Saba, Israel
- Meir MC
-
Tel Aviv, Israel
- Rabin MC
-
Tel-Aviv, Israel
- Sheaba MC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I
patients who will be treated in accordance with standard of care
|
Fibrin Patch
|
Active Comparator: II
patients for which the Fibrin Fleece will be applied directly on the active bleeding site.
|
Fibrin Patch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of successes at 10 minutes following randomization
Time Frame: 10 minutes
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of successes at 5 minutes following randomization
Time Frame: 5 minutes
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yoram Dekel, MD, Rabin MC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
December 23, 2007
First Submitted That Met QC Criteria
January 17, 2008
First Posted (Estimate)
January 18, 2008
Study Record Updates
Last Update Posted (Estimate)
November 6, 2009
Last Update Submitted That Met QC Criteria
November 5, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- FL-PN-002-IS
- MoH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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