PleuraSeal Post Market Study (Europe)

NCT ID: NCT00704171

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-12-31

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 thoractomy.

Conditions

Lung Disease; Pulmonary Lobectomy

Keywords

Elective pulmonary resection via open thoracotomy.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PleuraSeal

PleuraSeal Lung Sealant System

Group Type: EXPERIMENTAL

PleuraSeal Lung Sealant System

Intervention Type: DEVICE

Standard of Care

Standard tissue closure techniques (control) - sutures or staples only

Group Type: ACTIVE_COMPARATOR

Standard Tissue Closure Techniques

Intervention Type: PROCEDURE

Standard Tissue Closure Techniques (sutures and staples only)

PleuraSeal Lung Sealant System

Intervention Type: DEVICE

Interventions

Standard Tissue Closure Techniques

Standard Tissue Closure Techniques (sutures and staples only)

Intervention Type: PROCEDURE

PleuraSeal Lung Sealant System

Intervention Type: DEVICE

Other Intervention Names

Sutures or staples; PleuraSeal

Eligibility Criteria

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

• 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

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

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Doyle

Role: STUDY_DIRECTOR

Senior Director, Clinical Affairs at Covidien (formerly Confluent)

Paul De Leyn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Covidien

Bedford, Massachusetts, United States

Universitaetsklinik - Landeskrankenhaus Innsbruck

Innsbruck, , Austria

Otto Wagner Spital

Vienna, , Austria

Hopital Erasme

Brussels, , Belgium

University Hospitals Leuven

Leuven, , Belgium

VU-Medisch Centrum

Amsterdam, , Netherlands

Medical Centre Rotterdam Zuid

Rotterdam, , Netherlands

University Hospital - Zurich

Zurich, , Switzerland

Papworth Hospital

Cambridge, , United Kingdom

Countries

United States; Austria; Belgium; Netherlands; Switzerland; United Kingdom

Other Identifiers

LUN-06-002

Identifier Type: -

Identifier Source: org_study_id