NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

Not Applicable

Completed

Interventions: Device: ProGEL Pleural Air Leak Sealant with standard surgical closure
Device: ProGEL Pleural Air Leak Sealant without standard surgical closure
Other: Control

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.

Recruitment & Eligibility

Inclusion Criteria

Scheduled for an open thoracotomy for lung resection
Has at least one or more intraoperative visible air leak >= 2 mm following the lung resection surgery

Exclusion Criteria

Pregnant or breast feeding
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

Arm && Interventions

Group	Intervention	Description
ProGEL Pleural Air Leak Sealant with standard surgical closure	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 without standard surgical closure	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).
Control	Control	No treatment.

Primary Outcome Measures

Name	Time	Method
Safety Endpoints	90 days	* Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome * Renal adverse events * Cardiac adverse events * Death (all causes) * Hospital readmission

Secondary Outcome Measures

Name	Time	Method

Locations (18): WellStar Research Institute
🇺🇸
Atlanta, Georgia, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Greater Baltimore Medical Center
🇺🇸
Baltimore, Maryland, United States
Mass General Hospital
🇺🇸
Boston, Massachusetts, United States
UMass Memorial Medical
🇺🇸
Worcester, Massachusetts, United States
Beth Israel Deconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Swedish Cancer Institute
🇺🇸
Seattle, Washington, United States
Lancaster General Hospital
🇺🇸
Lancaster, Pennsylvania, United States
Jacksonville Center for Research
🇺🇸
Jacksonville, Florida, United States
Brigham Womens' Hospital
🇺🇸
Boston, Massachusetts, United States
St. Vincent Hospital and Health Care Center
🇺🇸
Indianapolis, Indiana, United States
St. Vincent Birmingham & St. Vincent East
🇺🇸
Birmingham, Alabama, United States
University of Alabama in Birmingham
🇺🇸
Birmingham, Alabama, United States
Moffit Cancer Center
🇺🇸
Tampa, Florida, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Virginia Commonwealth University Medical Center
🇺🇸
Richmond, Virginia, United States
Dean Foundation for Health, Research and Education, Inc.
🇺🇸
Madison, Wisconsin, United States