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
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.
July 16, 2014
Eric Vallieres, M.D.
Swedish Thoracic Surgery / First Hill
- 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
- 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