PleuraSeal Post Market Study (Europe)

Phase 4

Completed

• Conditions: Lung Disease; Pulmonary Lobectomy

• Registration Number: NCT00704171
• Lead Sponsor: Integra LifeSciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-24
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-12-21
• Results First Submitted QC: 2010-03-03
• Results First Posted: 2010-03-15
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	30 days	Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles

Secondary Outcome Measures

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

Trial Locations

Locations (9)

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