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 |
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).
(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
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
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Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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