CompletedNot applicableNCT02702921
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSurgeon's 'standard of care' stapler and Ethicon Powered Vascular Stapler

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 11, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Ethicon Endo-Surgery

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Ethicon Endo-Surgery
Interventions being studied
Device: Surgeon's 'standard of care' stapler; Device: Ethicon Powered Vascular Stapler
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Emory UniversityAtlanta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 11, 2018. Always confirm current availability with the study team.

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