Powered Echelon Device in VATS Surgery

Completed

Conditions studied: Non-small Cell Lung Cancer (NSCLC)

In brief

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).

Key facts

Study ID

NCT01843192

Run by

Ethicon Endo-Surgery

People needed

71

Starts

2013-05-01

Expected to finish

2014-05-01

Last updated by the study team

2015-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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