NCT01394978

NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 444 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Lung Tumor

Interventions

Type	Name	Description
OTHER	Control	Standard surgical techniques including staples and sutures.
DEVICE	ProGEL Pleural Air Leak Sealant with standard surgical closure	ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.
DEVICE	ProGEL Pleural Air Leak Sealant without standard surgical closure	ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.

Timeline

• Start date: 2011-06-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2011-07-15
• Last updated: 2021-07-15
• Results posted: 2017-07-11

Locations

18 sites across 1 country: United States