Powered Echelon Device in VATS Surgery



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:May 2013
End Date:June 2014

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A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures

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).


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
We found this trial at
4
sites
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Phoenix, AZ
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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mi
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Nashville, TN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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mi
from
Saint Louis, MO
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