NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lung Cancer, Lung Tumor

Intervention / Treatment
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* Other: Control
* Device: ProGEL Pleural Air Leak Sealant with standard surgical closure
* Device: ProGEL Pleural Air Leak Sealant without standard surgical closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>No treatment. | Other: Control<br>* Standard surgical techniques including staples and sutures.<br>|
| Experimental: ProGEL Pleural Air Leak Sealant with standard surgical closure<br>Standard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant. | Device: ProGEL Pleural Air Leak Sealant with standard surgical closure<br>* 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.<br>|
| Experimental: ProGEL Pleural Air Leak Sealant without standard surgical closure<br>Progel Pleural Air Leak Sealant without standard surgical closure (without suturing or stapling of visible air leaks incurred during resection of lung parenchyma). | Device: ProGEL Pleural Air Leak Sealant without standard surgical closure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoints | Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome Renal adverse events Cardiac adverse events Death (all causes) Hospital readmission | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleural air leak, Pulmonary resection, Open thoracotomy