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

June 23, 2008
September 4, 2014
January 2008
December 2008   (final data collection date for primary outcome measure)
  • 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
Proportion of subjects remaining air leak free from time of skin closure to hospital discharge. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00704171 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Lung Disease
  • Pulmonary Lobectomy
  • 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
  • Experimental: PleuraSeal
    PleuraSeal Lung Sealant System
    Intervention: Device: PleuraSeal Lung Sealant System
  • Active Comparator: Standard of Care
    Standard tissue closure techniques (control) - sutures or staples only
    Interventions:
    • Procedure: Standard Tissue Closure Techniques
    • Device: PleuraSeal Lung Sealant System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Netherlands,   Switzerland,   United Kingdom
 
NCT00704171
LUN-06-002
No
Jennifer Doyle - Director, Clinical Affairs, Confluent Surgical / Covidien
Integra LifeSciences Corporation
Covidien
Study Director: Jennifer Doyle Senior Director, Clinical Affairs at Covidien (formerly Confluent)
Principal Investigator: Paul De Leyn, MD, PhD University Hospitals Leuven
Integra LifeSciences Corporation
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP