Status:
COMPLETED
PleuraSeal Post Market Study (Europe)
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Lung Disease
Pulmonary Lobectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 thora...
Eligibility Criteria
Inclusion
- Pre-Operative
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00704171
Start Date
January 1 2008
End Date
December 1 2008
Last Update
October 27 2016
Active Locations (9)
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1
Covidien
Bedford, Massachusetts, United States, 01730
2
Universitaetsklinik - Landeskrankenhaus Innsbruck
Innsbruck, Austria
3
Otto Wagner Spital
Vienna, Austria
4
Hopital Erasme
Brussels, Belgium