NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
NCT ID: NCT01394978
Last Updated: 2021-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
444 participants
INTERVENTIONAL
2011-06-30
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
No treatment.
Control
Standard surgical techniques including staples and sutures.
ProGEL Pleural Air Leak Sealant with standard surgical closure
Standard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant.
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 Pleural Air Leak Sealant without standard surgical closure (without 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Has at least one or more intraoperative visible air leak \>= 2 mm following the lung resection surgery
Exclusion Criteria
* History of an allergic reaction to Human Serum Albumin
* Has a significant clinical disease or condition
* Had previous open thoracotomy procedures
* Unable to participate in all necessary study activities due to physical or mental limitations
18 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Robert J. Cerfolio, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama in Birmingham
Daniel L. Miller, MD
Role: PRINCIPAL_INVESTIGATOR
WellStar Research Institute
Locations
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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
Countries
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Other Identifiers
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NEO09-100
Identifier Type: -
Identifier Source: org_study_id
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