Status:
COMPLETED
Powered Echelon Device in VATS Surgery
Lead Sponsor:
Ethicon Endo-Surgery (Europe) GmbH
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Brief 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 6...
Detailed Description
The European prospective observational multi-center cohort study aims to collect real-world outcomes of consecutive patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lu...
Eligibility Criteria
Inclusion
- Histologically confirmed NSCLC (up to and including Stage II) for patients undergoing VATS lobectomy. For patients undergoing wedge resection for undiagnosed pulmonary nodule or metastasis from CRC, a malignant diagnosis may be confirmed post-operatively.
- Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung
- Willing to give consent and comply with evaluation and treatment schedule
- At least 18 years of age
Exclusion
- 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);
- Prior history of VATS or open lung surgery
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT01808430
Start Date
March 1 2013
End Date
May 1 2014
Last Update
February 12 2015
Active Locations (1)
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1
Professor Peter Licht
Odense, Denmark, 5000