Powered Surgical Stapler in VATS Lung Resection Procedures in China

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in China

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Device: Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 18 years of age. Exclusion Criteria: Subjects satisfying the following criteria will be eligible for participation in this study: 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 18 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutter|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of prolonged air leaks |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |