NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

C. R. Bard

Status: Completed

Conditions: Lung Tumor; Lung Cancer

Treatments: Device: ProGEL Pleural Air Leak Sealant with standard surgical closure; Device: ProGEL Pleural Air Leak Sealant without standard surgical closure; Other: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01394978

NEO09-100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 444 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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444 participants in 3 patient groups

Control

Other group

Description:

No treatment.

Treatment:

Other: Control

ProGEL Pleural Air Leak Sealant with standard surgical closure

Experimental group

Description:

Standard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant.

Treatment:

Device: ProGEL Pleural Air Leak Sealant with standard surgical closure

ProGEL Pleural Air Leak Sealant without standard surgical closure

Experimental group

Description:

Progel Pleural Air Leak Sealant without standard surgical closure (without suturing or stapling of visible air leaks incurred during resection of lung parenchyma).

Treatment:

Device: ProGEL Pleural Air Leak Sealant without standard surgical closure