Back to resultsA Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler
Sponsored by
About this trial
This is an interventional other trial for Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects with a confirmed or suspected diagnosis of stage IA to stage IIB non-small cell lung cancer scheduled for lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)7;
- Subjects scheduled for VATS lobectomy in accordance with their institution's SOC;
- Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- ASA score < 3;
- No prior history of VATS 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
- 18-75 years of age (inclusive).
Exclusion Criteria:
- Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
- Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure);
- Uncontrolled diabetes mellitus;
- End stage renal or liver disease;
- History of severe cardiovascular disease;
- FEV1% <50% or severe COPD;
- Prior chemotherapy or radiation for lung cancer;
- Scheduled concurrent surgical procedure other than diagnostic wedge resection followed by lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
- Robotic-assisted procedure;
- Women who are pregnant or lactating at the time of screening;
- Physical or psychological condition which would impair study participation;
- The subject is judged unsuitable for study participation by the Investigator for any other reason;
- Participation in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; or
- Unable or unwilling to attend follow-up visits and examinations.
Sites / Locations
- Beijing Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Powered vascular stapler
Arm Description
Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler
Outcomes
Primary Outcome Measures
Incidence of Intra-Operative Hemostatic Interventions
Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of 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).
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 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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03056300
Brief Title
A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 11, 2017 (Actual)
Primary Completion Date
May 26, 2017 (Actual)
Study Completion Date
May 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this trial is to demonstrate the effectiveness of the powered vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during Video-Assisted Thoracoscopic Lobectomy.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Powered vascular stapler
Arm Type
Experimental
Arm Description
Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler
Intervention Type
Device
Intervention Name(s)
Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler
Intervention Description
Powered Vascular Stapler used on vessels
Primary Outcome Measure Information:
Title
Incidence of Intra-Operative Hemostatic Interventions
Description
Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of 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
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 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 follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a confirmed or suspected diagnosis of stage IA to stage IIB non-small cell lung cancer scheduled for lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)7;
Subjects scheduled for VATS lobectomy in accordance with their institution's SOC;
Performance status 0-1 (Eastern Cooperative Oncology Group classification);
ASA score < 3;
No prior history of VATS 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
18-75 years of age (inclusive).
Exclusion Criteria:
Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure);
Uncontrolled diabetes mellitus;
End stage renal or liver disease;
History of severe cardiovascular disease;
FEV1% <50% or severe COPD;
Prior chemotherapy or radiation for lung cancer;
Scheduled concurrent surgical procedure other than diagnostic wedge resection followed by lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
Robotic-assisted procedure;
Women who are pregnant or lactating at the time of screening;
Physical or psychological condition which would impair study participation;
The subject is judged unsuitable for study participation by the Investigator for any other reason;
Participation in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; or
Unable or unwilling to attend follow-up visits and examinations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keneng Chen
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shugeng Gao
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hu Jian
Organizational Affiliation
The first affiliated hospital Zhejiang University/Hangzhou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Jian
Organizational Affiliation
Beijing Friendship hospital/Hangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing City
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies
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