Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy
Fleece
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
2 other identifiers
interventional
30
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2008
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedNovember 6, 2009
November 1, 2009
9 months
December 23, 2007
November 5, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of successes at 10 minutes following randomization
10 minutes
Secondary Outcomes (1)
Proportion of successes at 5 minutes following randomization
5 minutes
Study Arms (2)
I
EXPERIMENTALpatients who will be treated in accordance with standard of care
II
ACTIVE COMPARATORpatients for which the Fibrin Fleece will be applied directly on the active bleeding site.
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing elective open partial nephrectomy
- Patients must be willing to participate in the study, and provide written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Bnei-Zion MC
Haifa, Israel
Meir MC
Kfar Saba, Israel
Rabin MC
Tel Aviv, Israel
Sheaba MC
Tel Aviv, Israel
Related Publications (1)
Nativ O, Patel B, Shen J, Batiller J, Horn S, Hart JC. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: results of an open-label phase I and a randomized, standard-of-care-controlled phase I/II study. BMC Nephrol. 2012 Nov 8;13:147. doi: 10.1186/1471-2369-13-147.
PMID: 23137020DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoram Dekel, MD
Rabin MC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 23, 2007
First Posted
January 18, 2008
Study Start
February 1, 2008
Primary Completion
November 1, 2008
Study Completion
February 1, 2009
Last Updated
November 6, 2009
Record last verified: 2009-11