NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

Completed · Not applicable

Conditions studied: Lung Cancer, Lung Tumor

In brief

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.

Key facts

Study ID

NCT01394978

Run by

C. R. Bard

People needed

444

Starts

2011-06-01

Expected to finish

2016-02-01

Last updated by the study team

2021-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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