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Title	NOVEL Lung Trial: Normothermic Ex-Vivo Lung Perfusion as an Assessment of Extended/Marginal Donor Lungs
Trial Start Date	6/1/2011
Trial End Date	3/31/2014
Principal Investigator	Frank D'Ovidio, MD, PhD
Description	This is a two arm, non-randomized, open-label, study to evaluate the 30 day mortality of patients undergoing lung transplant lungs from marginal or extended donors treated with ex vivo lung perfusion (EVLP) versus those undergoing lung transplant with lungs considered transplant suitable. The University of Toronto group has systematically studied and developed an effective perfusion methodology to maintain donor lungs ex vivo (outside of the body) at physiologic body temperatures without adding further injury. Preclinical data shows that ex vivo perfusion with STEEN solution is as good if not better than the standard cold static preservation.The study proposes to use the EVLP technique to improve donor lung assessment preimplantation and, thereby safely increase the number of available lungs for transplant. If the lungs demonstrate a favorable ex vivo evaluation, the lungs will be transplanted into a patient.
Inclusion Criteria	Any male or female, 18 years of age or older, who requires a single or bilateral lung transplant and provides a legally effective informed consent.
URL
Clinical Areas	Chronic Obstructive Pulmonary Disease; Cystic Fibrosis; Emphysema; Mesothelioma; Pulmonary Fibrosis; Lung Transplant
Contact	For more information, please contact Lyn Goldsmith, Phone: 212-342-0261 E-mail: lg2240@columbia.edu