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PleuraSeal Post Market Study (Europe)

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT00704171
First received: June 23, 2008
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
Results First Received: December 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Lung Disease
Pulmonary Lobectomy
Interventions: Procedure: Standard Tissue Closure Techniques
Device: PleuraSeal Lung Sealant System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between January 28, 2008 and October 21, 2008, a total of 161 subjects were consented and screened for potential study participation at 8 institutions (hospitals). Of these subjects, 121 were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were evaluated for pre-operative and intra-operative eligibility criteria. Randomization occurred intra-operatively.

Reporting Groups
  Description
PleuraSeal PleuraSeal Lung Sealant System
Standard of Care Standard tissue closure techniques (control) - sutures or staples only

Participant Flow:   Overall Study
    PleuraSeal     Standard of Care  
STARTED     62     59  
COMPLETED     61 [1]   59 [2]
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  
[1] One subject withdrew consent prior to study completion. No reason given.
[2] All control subjects completed the study.



  Baseline Characteristics
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Reporting Groups
  Description
PleuraSeal PleuraSeal Lung Sealant System
Standard of Care Standard tissue closure techniques (control) - sutures or staples only
Total Total of all reporting groups

Baseline Measures
    PleuraSeal     Standard of Care     Total  
Number of Participants  
[units: participants]
 		  62     59     121  
Age  
[units: years]
Mean ± Standard Deviation 		  61.5  ± 9.1     62.8  ± 10.8     62.1  ± 9.9  
Gender  
[units: participants]
 		     
Female     26     22     48  
Male     36     37     73  
Race/Ethnicity, Customized  
[units: participants]
 		     
Caucasian     61     55     116  
African     0     1     1  
Asian     0     1     1  
Hispanic     0     1     1  
Other     1     1     2  
Region of Enrollment  
[units: participants]
 		     
Netherlands     9     6     15  
Belgium     14     14     28  
United Kingdom     6     4     10  
Austria     32     30     62  
Switzerland     1     5     6  
Nicotine Use  
[units: participants]
 		     
History     31     34     65  
Current     22     17     39  
Never     9     8     17  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation 		  25.86  ± 4.73     26.35  ± 4.55     26.10  ± 4.63  
Height  
[units: cm]
Mean ± Standard Deviation 		  169.5  ± 8.8     169.4  ± 9.6     169.4  ± 9.1  
Weight  
[units: kg]
Mean ± Standard Deviation 		  74.46  ± 15.35     75.57  ± 13.96     75.00  ± 14.64  



  Outcome Measures
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1.  Primary:   Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.   [ Time Frame: 30 days ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge   [ Time Frame: 30 days ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.   [ Time Frame: Intra-operatively, time of study procedure ]
  Show Outcome Measure 3

4.  Secondary:   Time From Skin Closure to Last Observable Air Leak.   [ Time Frame: 30 days ]
  Show Outcome Measure 4

5.  Secondary:   Duration of Chest Drainage   [ Time Frame: 30 days ]
  Show Outcome Measure 5

6.  Secondary:   Duration of Hospitalization   [ Time Frame: 30 days ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Jennifer L. Doyle, Global Director of Clinical Affairs
Organization: Covidien
phone: 781-839-1770
e-mail: jennifer.doyle@covidien.com


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: June 14, 2011
Health Authority: Belgium: Institutional Review Board