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.
Checked against the public recordLast updated Oct 11, 2018 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.