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Project Title:
Cytosorb Clinical Project Development
Funding Agency:
RenalTech International, LLC
Total Project Period:
Jan 01, 2004 - Dec 31, 2004
Principal Investigator:
John Kellum, Jr, MD
Project Summary:
We propose to develop a clinical study plan that will address the following: feasibility, cost sample size, patient types and study endpoints. The focus of these studies will be on safety and feasibility. Phase I Clinical trial development will be carried out in conjunction with the sepsis advisory board and the research teams at the University of Pittsburgh and RenalTech International. This proposal covers the design of Phase I Clinical Trials; conduct and management of these trials is beyond the scope of the current project.
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