Lung Cancer Clinical Trial

Powered Echelon Device in VATS Surgery

Summary

This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Suspected or confirmed NSCLC (up to and including Stage II)
Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung
Performance status 0-1 (Eastern Cooperative Oncology Group classification)
ASA score < 3
No prior history of VATS or open lung surgery
Willing to give consent and comply with study-related evaluation and treatment schedule

Exclusion Criteria:

Active bacterial infection or fungal infection;
Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure)
Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure
Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed)
Pregnancy
Physical or psychological condition which would impair study participation;
The patient is judged unsuitable for study participation by the Investigator for any other reason; or
Unable or unwilling to attend follow-up visits and examinations

Study is for people with:

Lung Cancer

Estimated Enrollment:

71

Study ID:

NCT01843192

Recruitment Status:

Completed

Sponsor:

Ethicon Endo-Surgery

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There are 4 Locations for this study

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Dignity Health, St. Joseph's Hospital & Medical Center
Phoenix Arizona, 85013, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Washington University School of Medicine
St. Louis Missouri, 63110, United States
Vanderbilt University
Nashville Tennessee, 37232, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

71

Study ID:

NCT01843192

Recruitment Status:

Completed

Sponsor:


Ethicon Endo-Surgery

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