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PleuraSeal Post Market Study (Europe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00704171
Recruitment Status : Completed
First Posted : June 24, 2008
Results First Posted : March 15, 2010
Last Update Posted : October 27, 2016
Medtronic - MITG
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
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 Name: Sutures or staples

Device: PleuraSeal Lung Sealant System
Other Name: PleuraSeal

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

  2. Time From Skin Closure to Last Observable Air Leak. [ Time Frame: 30 days ]
  3. Duration of Chest Drainage [ Time Frame: 30 days ]
  4. Duration of Hospitalization [ Time Frame: 30 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00704171

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United States, Massachusetts
Bedford, Massachusetts, United States, 01730
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
United Kingdom
Papworth Hospital
Cambridge, United Kingdom
Sponsors and Collaborators
Integra LifeSciences Corporation
Medtronic - MITG
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Study Director: Jennifer Doyle Senior Director, Clinical Affairs at Covidien (formerly Confluent)
Principal Investigator: Paul De Leyn, MD, PhD Universitaire Ziekenhuizen Leuven

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Responsible Party: Integra LifeSciences Corporation Identifier: NCT00704171    
Other Study ID Numbers: LUN-06-002
First Posted: June 24, 2008    Key Record Dates
Results First Posted: March 15, 2010
Last Update Posted: October 27, 2016
Last Verified: September 2016
Keywords provided by Integra LifeSciences Corporation:
Elective pulmonary resection via open thoracotomy.
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases