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Completed

NCT Number: NCT02702921

Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgeon's 'standard of care' stapler

Device

Ethicon Powered Vascular Stapler

Device

Primary outcomes

  1. Incidence of Intra-Operative Hemostatic Intervention

    Time frame: Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours

    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 outcomes

  1. Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding

    Time frame: Post-Op through 4 Week Followup

    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).

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Official study title

A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in VAT Lobectomies

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2016
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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