Spots Global Cancer Trial Database for NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
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Trial Identification
Brief Title: NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
Official Title: AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure
Study ID: NCT01394978
Study Description
Brief Summary: The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.
Detailed Description: Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Vincent Birmingham & St. Vincent East, Birmingham, Alabama, United States
University of Alabama in Birmingham, Birmingham, Alabama, United States
Jacksonville Center for Research, Jacksonville, Florida, United States
Moffit Cancer Center, Tampa, Florida, United States
WellStar Research Institute, Atlanta, Georgia, United States
Emory University, Atlanta, Georgia, United States
Indiana University, Indianapolis, Indiana, United States
St. Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Mass General Hospital, Boston, Massachusetts, United States
Brigham Womens' Hospital, Boston, Massachusetts, United States
Beth Israel Deconess Medical Center, Boston, Massachusetts, United States
UMass Memorial Medical, Worcester, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Lancaster General Hospital, Lancaster, Pennsylvania, United States
Virginia Commonwealth University Medical Center, Richmond, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Dean Foundation for Health, Research and Education, Inc., Madison, Wisconsin, United States
Contact Details
Name: Robert J. Cerfolio, MD
Affiliation: University of Alabama in Birmingham
Role: PRINCIPAL_INVESTIGATOR
Name: Daniel L. Miller, MD
Affiliation: WellStar Research Institute
Role: PRINCIPAL_INVESTIGATOR
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