Status:
COMPLETED
Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
19+ years
Brief Summary
Collection of 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 d...
Detailed Description
This clinical trial assessed the use of a powered stapler for transection in VATS lung resection, where there is currently limited published clinical data. The primary study endpoint was occurrence an...
Eligibility Criteria
Inclusion
- Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
- 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; and
- At least 19 years of age.
Exclusion
- Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
- Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain 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 :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02196675
Start Date
July 1 2014
End Date
January 1 2015
Last Update
July 15 2016
Active Locations (4)
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1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 410-769
2
Samsung Medical Center
Seoul, Seoul, South Korea, 135-710
3
Asan Medical Center
Seoul, Seoul, South Korea, 138-736
4
Korean University Guro Hospital
Seoul, Seoul, South Korea, 152-703