Status:
COMPLETED
Powered Echelon Device in VATS Surgery
Lead Sponsor:
Ethicon Endo-Surgery
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01843192
Start Date
May 1 2013
End Date
May 1 2014
Last Update
June 18 2015
Active Locations (4)
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1
Dignity Health, St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States, 85013
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
4
Vanderbilt University
Nashville, Tennessee, United States, 37232