PleuraSeal Post Market Study (Europe)

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by:
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT00704171
First received: June 23, 2008
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Lung Disease
Pulmonary Lobectomy
Procedure: Standard Tissue Closure Techniques
Device: PleuraSeal Lung Sealant System
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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:
  • Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved. [ Time Frame: Intra-operatively, time of study procedure ] [ Designated as safety issue: No ]
    Success is defined as no presence of air leak intra-operatively.

  • Time From Skin Closure to Last Observable Air Leak. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Duration of Chest Drainage [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Duration of Hospitalization [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PleuraSeal
PleuraSeal Lung Sealant System
Device: PleuraSeal Lung Sealant System
Other Name: PleuraSeal
Active Comparator: Standard of Care
Standard tissue closure techniques (control) - sutures or staples only
Procedure: Standard Tissue Closure Techniques
Standard Tissue Closure Techniques (sutures and staples only)
Other Names:
  • Standard Tissue Closure Techniques
  • Sutures or staples
Device: PleuraSeal Lung Sealant System
Other Name: PleuraSeal

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704171

Locations
United States, Massachusetts
Covidien
Bedford, Massachusetts, United States, 01730
Austria
Universitaetsklinik - Landeskrankenhaus Innsbruck
Innsbruck, Austria
Otto Wagner Spital
Vienna, Austria
Belgium
Hopital Erasme
Brussels, Belgium
University Hospitals Leuven
Leuven, Belgium
Netherlands
VU-Medisch Centrum
Amsterdam, Netherlands
Medical Centre Rotterdam Zuid
Rotterdam, Netherlands
Switzerland
University Hospital - Zurich
Zurich, Switzerland
United Kingdom
Papworth Hospital
Cambridge, United Kingdom
Sponsors and Collaborators
Integra LifeSciences Corporation
Covidien
Investigators
Study Director: Jennifer Doyle Senior Director, Clinical Affairs at Covidien (formerly Confluent)
Principal Investigator: Paul De Leyn, MD, PhD University Hospitals Leuven
  More Information

No publications provided

Responsible Party: Jennifer Doyle - Director, Clinical Affairs, Confluent Surgical / Covidien
ClinicalTrials.gov Identifier: NCT00704171     History of Changes
Other Study ID Numbers: LUN-06-002
Study First Received: June 23, 2008
Results First Received: December 21, 2009
Last Updated: September 4, 2014
Health Authority: Belgium: Institutional Review Board

Keywords provided by Integra LifeSciences Corporation:
Elective pulmonary resection via open thoracotomy.

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014