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
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000

Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Click here to add this to my saved trials

Click here to add this to my saved trials

Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
Click here to add this to my saved trials

Click here to add this to my saved trials
