PleuraSeal Post Market Study (Europe)
Primary Purpose
Lung Disease, Pulmonary Lobectomy
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Standard Tissue Closure Techniques
PleuraSeal Lung Sealant System
Sponsored by
About this trial
This is an interventional treatment trial for Lung Disease focused on measuring Elective pulmonary resection via open thoracotomy.
Eligibility 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
Sites / Locations
- Covidien
- Universitaetsklinik - Landeskrankenhaus Innsbruck
- Otto Wagner Spital
- Hopital Erasme
- University Hospitals Leuven
- VU-Medisch Centrum
- Medical Centre Rotterdam Zuid
- University Hospital - Zurich
- Papworth Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PleuraSeal
Standard of Care
Arm Description
PleuraSeal Lung Sealant System
Standard tissue closure techniques (control) - sutures or staples only
Outcomes
Primary Outcome Measures
Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.
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
Secondary Outcome Measures
Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.
Success is defined as no presence of air leak intra-operatively.
Time From Skin Closure to Last Observable Air Leak.
Duration of Chest Drainage
Duration of Hospitalization
Full Information
NCT ID
NCT00704171
First Posted
June 23, 2008
Last Updated
September 22, 2016
Sponsor
Integra LifeSciences Corporation
Collaborators
Medtronic - MITG
1. Study Identification
Unique Protocol Identification Number
NCT00704171
Brief Title
PleuraSeal Post Market Study (Europe)
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 Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation
Collaborators
Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease, Pulmonary Lobectomy
Keywords
Elective pulmonary resection via open thoracotomy.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PleuraSeal
Arm Type
Experimental
Arm Description
PleuraSeal Lung Sealant System
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard tissue closure techniques (control) - sutures or staples only
Intervention Type
Procedure
Intervention Name(s)
Standard Tissue Closure Techniques
Other Intervention Name(s)
Sutures or staples
Intervention Description
Standard Tissue Closure Techniques (sutures and staples only)
Intervention Type
Device
Intervention Name(s)
PleuraSeal Lung Sealant System
Other Intervention Name(s)
PleuraSeal
Primary Outcome Measure Information:
Title
Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.
Time Frame
30 days
Title
Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge
Description
Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.
Description
Success is defined as no presence of air leak intra-operatively.
Time Frame
Intra-operatively, time of study procedure
Title
Time From Skin Closure to Last Observable Air Leak.
Time Frame
30 days
Title
Duration of Chest Drainage
Time Frame
30 days
Title
Duration of Hospitalization
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Doyle
Organizational Affiliation
Senior Director, Clinical Affairs at Covidien (formerly Confluent)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul De Leyn, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covidien
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States
Facility Name
Universitaetsklinik - Landeskrankenhaus Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Otto Wagner Spital
City
Vienna
Country
Austria
Facility Name
Hopital Erasme
City
Brussels
Country
Belgium
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium
Facility Name
VU-Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
Medical Centre Rotterdam Zuid
City
Rotterdam
Country
Netherlands
Facility Name
University Hospital - Zurich
City
Zurich
Country
Switzerland
Facility Name
Papworth Hospital
City
Cambridge
Country
United Kingdom
12. IPD Sharing Statement
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PleuraSeal Post Market Study (Europe)
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