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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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

Last updated:

9/12/2013

NCT ID:

NCT01394978

IRB Number:

11-006769