PleuraSeal Post Market Study (Europe)

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Disease; Pulmonary Lobectomy
• Intervention / Treatment: Device: PleuraSeal Lung Sealant System; Procedure: Standard Tissue Closure Techniques

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Universitaetsklinik - Landeskrankenhaus Innsbruck
  • Vienna, Austria
    • Otto Wagner Spital
• Belgium
  • Brussels, Belgium
    • Hopital Erasme
  • Leuven, Belgium
    • University Hospitals Leuven
• Netherlands
  • Amsterdam, Netherlands
    • VU-Medisch Centrum
  • Rotterdam, Netherlands
    • Medical Centre Rotterdam Zuid
• Switzerland
  • Zurich, Switzerland
    • University Hospital - Zurich
• United Kingdom
  • Cambridge, United Kingdom
    • Papworth Hospital
• United States
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • Covidien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Collaborators: Medtronic - MITG
• Investigators: Study Director: Jennifer Doyle, Senior Director, Clinical Affairs at Covidien (formerly Confluent); Principal Investigator: Paul De Leyn, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: June 23, 2008
• First Submitted That Met QC Criteria: June 23, 2008
• First Posted (Estimate): June 24, 2008

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Elective pulmonary resection via open thoracotomy.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: LUN-06-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No