A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies
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|ClinicalTrials.gov Identifier: NCT03056300|
Recruitment Status : Completed
First Posted : February 17, 2017
Results First Posted : December 17, 2018
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Device: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||January 11, 2017|
|Actual Primary Completion Date :||May 26, 2017|
|Actual Study Completion Date :||May 26, 2017|
Experimental: Powered vascular stapler
Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler
Device: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler
Powered Vascular Stapler used on vessels
- Incidence of Intra-Operative Hemostatic Interventions [ Time Frame: Intra-Operative ]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 [ Time Frame: Post-op through 4 week follow-up ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056300
|Beijing Cancer Hospital|
|Beijing City, China|
|Principal Investigator:||Keneng Chen||Beijing Cancer Hospital|
|Principal Investigator:||Shugeng Gao||Cancer Institute and Hospital, Chinese Academy of Medical Services|
|Principal Investigator:||Hu Jian||The first affiliated hospital Zhejiang University/Hangzhou|
|Principal Investigator:||Li Jian||Beijing Friendship hospital/Hangzhou|