444
Participants
Start Date
June 30, 2011
Primary Completion Date
February 29, 2016
Study Completion Date
February 29, 2016
Control
Standard surgical techniques including staples and sutures.
ProGEL Pleural Air Leak Sealant with standard surgical closure
ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.
ProGEL Pleural Air Leak Sealant without standard surgical closure
ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.
Lancaster General Hospital, Lancaster
Greater Baltimore Medical Center, Baltimore
Virginia Commonwealth University Medical Center, Richmond
WellStar Research Institute, Atlanta
Emory University, Atlanta
Jacksonville Center for Research, Jacksonville
Moffit Cancer Center, Tampa
St. Vincent Birmingham & St. Vincent East, Birmingham
University of Alabama in Birmingham, Birmingham
Indiana University, Indianapolis
St. Vincent Hospital and Health Care Center, Indianapolis
Dean Foundation for Health, Research and Education, Inc., Madison
Mayo Clinic, Rochester
Swedish Cancer Institute, Seattle
Mass General Hospital, Boston
Brigham Womens' Hospital, Boston
Beth Israel Deconess Medical Center, Boston
UMass Memorial Medical, Worcester
Lead Sponsor
C. R. Bard
INDUSTRY