PleuraSeal Post Market Study (Europe)

Study Overview
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Brief Summary
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To further characterize the PleuraSeal Sealant System as compared to standard of care (sutures and staples only) in subjects undergoing an elective pulmonary lobectomy and segmentectomy via open thoractomy.

Official Title
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Prospective Multi-Center Randomized Post Market Study to Evaluate the PleuraSeal Sealant System as Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy

Conditions
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Lung Disease, Pulmonary Lobectomy

Intervention / Treatment
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* Procedure: Standard Tissue Closure Techniques
* Device: PleuraSeal Lung Sealant System


Participation Criteria
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Eligibility Criteria
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Pre-Operative Inclusion Criteria: Subjects 18 years of age or older Scheduled for an elective pulmonary lobectomy and segmentectomy (limited resection in case of reduced functional operability) in one or more lobes via an open thoracotomy Subject or authorized representative has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Ethics Committee of teh respective clinical site Pre-Operative Exclusion Criteria: Documented history of bleeding disorders and/or severely altered renal or hepatic function Compromised immune system (e.g., HIV/acquired immunodeficiency syndrome, immunosuppressive therapy) Prior ipsilateral thoracotomy Subject with Tuberculosis Extensive adhesions from previous thoracic trauma or surgery Undergoing lung volume reduction surgery, wedge resection, pneumonectomy, sleeve resection or bronchoplasty, blebectomy, bullectomy, pleurodesis, lung transplant, or living lobe transplant donor Subject has active systemic or pulmonary infection Treated with chronic steroid therapy unless discontinued more than 6 weeks prior to surgery (standard acute perioperative steroids are permitted). For purposes of this protocol, chronic steroid therapy is defined as greater than 4 weeks Pregnant (documented by pregnancy test), breast-feeding, or that wish to become pregnant during the course of the study or not willing to use birth control (e.g. IUD; oral, transdermal or parenteral contraceptives; abstinence) Documented history of uncontrolled diabetes Subject has an estimated life expectancy of less than 6 months Currently enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study Congestive heart failure, cor pulmonale, or other condition that, in the opinion of the investigator, may jeopardize the subject's well-being and/or negatively impact the interpretation of data collected during the clinical study Unable to comply with the study requirements or follow-up schedule Intra-Operative Inclusion Criteria: At least one intra-operative air leak identified during lung submersion leak test after the initial closure is completed Hemostasis must be confirmed prior to randomization Intra-Operative Exclusion Criteria: Procedure performed via VATS only Air leaks originating from bronchioles >1 mm in diameter that cannot be primarily closed or a residual tidal volume loss of >=30% Extensive intra-thoracic adhesions present Exploratory thoracotomy performed only Pneumonectomy, wedge resection, sleeve resection, pleurodesis, bronchoplasty, blebectomy or bullectomy performed Incidental finding of any other pre-operative exclusion criteria Use of buttressing materials or other non-autologous staple/suture line reinforcement or other surgical sealants when used for pulmonary sealing (i.e., use of hemostatic agents for hemostasis is permitted); however, the sealant should not be applied over intact hemostatic material and all hemostat should be removed prior to sealant application Investigator determines that participation in the study may jeopardize the safety or welfare of the subject

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PleuraSeal<br>PleuraSeal Lung Sealant System | Device: PleuraSeal Lung Sealant System<br> <br> * Other names: PleuraSeal;|
| Active Comparator: Standard of Care<br>Standard tissue closure techniques (control) - sutures or staples only | Procedure: Standard Tissue Closure Techniques<br>* Standard Tissue Closure Techniques (sutures and staples only)<br>* Other names: Sutures or staples;Device: PleuraSeal Lung Sealant System<br> <br> * Other names: PleuraSeal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge. |  | 30 days | 
| Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge | Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved. | Success is defined as no presence of air leak intra-operatively. | Intra-operatively, time of study procedure | 
| Time From Skin Closure to Last Observable Air Leak. |  | 30 days | 
| Duration of Chest Drainage |  | 30 days | 
| Duration of Hospitalization |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elective pulmonary resection via open thoracotomy.