Non-small Cell Lung Cancer
Conditions
Brief summary
This prospective, single-arm multi-center study will provide clinical data in an observational setting using the Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutters (study Endocutter). Individuals undergoing VATS lobectomy for suspected or confirmed Non Small Cell Lung Cancer (NSCLC), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC), and who meet study entry criteria, may be enrolled. Study procedures will include a wedge resection, wedge resection followed by lobectomy of the same lobe, or lobectomy.
Interventions
DEVICEEchelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutter
Sponsors
Ethicon Endo-Surgery
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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); 2. Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung; 3. Performance status 0-1 (Eastern Cooperative Oncology Group classification); 4. ASA score \< 3; 5. No prior history of VATS or open lung surgery; 6. Willing to give consent and comply with study-related evaluation and treatment schedule; and 7. At least 18 years of age.
Exclusion criteria
Subjects satisfying the following criteria will be eligible for participation in this study: 1. 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); 2. Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung; 3. Performance status 0-1 (Eastern Cooperative Oncology Group classification); 4. ASA score \< 3; 5. No prior history of VATS or open lung surgery; 6. Willing to give consent and comply with study-related evaluation and treatment schedule; and 7. At least 18 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of prolonged air leaks | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| 2.Occurrence of postoperative air leaks | 30 days |
| Length of stay (LOS) | 30 days |
| Volume of estimated intra-operative blood loss | Intra-operative |
| 5.Time to chest tube removal | 30 days |
Countries
China
Outcome results
None listed