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A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056300
Recruitment Status : Completed
First Posted : February 17, 2017
Results First Posted : December 17, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Device: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : January 11, 2017
Actual Primary Completion Date : May 26, 2017
Actual Study Completion Date : May 26, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).

  2. 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).




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. Subjects scheduled for VATS lobectomy in accordance with their institution's SOC;
  3. Performance status 0-1 (Eastern Cooperative Oncology Group classification);
  4. ASA score < 3;
  5. No prior history of VATS or open lung surgery (on the lung in which the procedure will be performed);
  6. Willing to give consent and comply with study-related evaluation and treatment schedule; and
  7. 18-75 years of age (inclusive).

Exclusion Criteria:

  1. Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
  2. Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure);
  3. Uncontrolled diabetes mellitus;
  4. End stage renal or liver disease;
  5. History of severe cardiovascular disease;
  6. FEV1% <50% or severe COPD;
  7. Prior chemotherapy or radiation for lung cancer;
  8. 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);
  9. Robotic-assisted procedure;
  10. Women who are pregnant or lactating at the time of screening;
  11. Physical or psychological condition which would impair study participation;
  12. The subject is judged unsuitable for study participation by the Investigator for any other reason;
  13. Participation in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; or
  14. Unable or unwilling to attend follow-up visits and examinations.

Information from the National Library of Medicine

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


Locations
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China
Beijing Cancer Hospital
Beijing City, China
Sponsors and Collaborators
Ethicon, Inc.
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Ethicon, Inc.:
Study Protocol  [PDF] February 11, 2016
Statistical Analysis Plan  [PDF] July 6, 2017

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Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT03056300    
Other Study ID Numbers: ESC-14-006
First Posted: February 17, 2017    Key Record Dates
Results First Posted: December 17, 2018
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases