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?

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.

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:

7/23/2014

NCT ID:

NCT01394978

IRB Number:

11-006769