PleuraSeal Post Market Study (Europe)
Condition: Lung Disease; Pulmonary Lobectomy
MeSH terms: Lung Diseases
Intervention: Standard Tissue Closure Techniques; PleuraSeal Lung Sealant System
Intervention description: Standard Tissue Closure Techniques (sutures and staples only)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Elective pulmonary resection via open thoracotomy.

Summary:

      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.
    

Eligibility criteria:

        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