Back to resultsPowered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgeon's 'standard of care' stapler
Ethicon Powered Vascular Stapler
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects with a confirmed or suspected diagnosis of stage IA to stage IIIA non-small cell lung cancer scheduled for a lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)5;
- Subjects scheduled for VATS lobectomy in accordance with their institution's Standard Of Care;
- Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- American Society of Anesthesiologists (ASA) score </= 3;
- No prior history of VAT or open lung surgery (on the lung in which the procedure will be performed);
- Willing to give consent and comply with study-related evaluation and treatment schedule; and
- At least 18 years of age.
Exclusion Criteria
- Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment);
- Pregnancy;
- Physical or psychological condition which would impair study participation; or
- The subject is judged unsuitable for study participation by the Investigator for any other reason.
Sites / Locations
- Emory University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Surgeon's 'standard of care' stapler
Ethicon Powered Vascular Stapler
Arm Description
Surgeon's current standard of care stapler
Ethicon Powered Vascular Stapler
Outcomes
Primary Outcome Measures
Incidence of Intra-Operative Hemostatic Intervention
Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Pulmonary Artery and Pulmonary Vein during Video Assisted Thoracoscopic lobectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).
Secondary Outcome Measures
Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding
Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of SOC or PVS:
Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection).
No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02702921
Brief Title
Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies
Official Title
A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in VAT Lobectomies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon Endo-Surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current Standard Of Care stapler (for Pulmonary Artery/Pulmonary Vein transection) and powered vascular stapler.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgeon's 'standard of care' stapler
Arm Type
Active Comparator
Arm Description
Surgeon's current standard of care stapler
Arm Title
Ethicon Powered Vascular Stapler
Arm Type
Experimental
Arm Description
Ethicon Powered Vascular Stapler
Intervention Type
Device
Intervention Name(s)
Surgeon's 'standard of care' stapler
Intervention Type
Device
Intervention Name(s)
Ethicon Powered Vascular Stapler
Primary Outcome Measure Information:
Title
Incidence of Intra-Operative Hemostatic Intervention
Description
Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Pulmonary Artery and Pulmonary Vein during Video Assisted Thoracoscopic lobectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).
Time Frame
Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours
Secondary Outcome Measure Information:
Title
Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding
Description
Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of SOC or PVS:
Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection).
No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).
Time Frame
Post-Op through 4 Week Followup
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a confirmed or suspected diagnosis of stage IA to stage IIIA non-small cell lung cancer scheduled for a lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)5;
Subjects scheduled for VATS lobectomy in accordance with their institution's Standard Of Care;
Performance status 0-1 (Eastern Cooperative Oncology Group classification);
American Society of Anesthesiologists (ASA) score </= 3;
No prior history of VAT or open lung surgery (on the lung in which the procedure will be performed);
Willing to give consent and comply with study-related evaluation and treatment schedule; and
At least 18 years of age.
Exclusion Criteria
Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment);
Pregnancy;
Physical or psychological condition which would impair study participation; or
The subject is judged unsuitable for study participation by the Investigator for any other reason.
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=11732&filename=ESC-15-001%20Protocol%20FINAL%20with%20NCT%20ID.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=11732&filename=ESC-15-001%20Final%20Protocol%20VATS%2011NOV2015_Redacted.pdf
Description
Related Info
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Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies
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