Powered Surgical Stapler in VATS Lung Resection Procedures in China

Ethicon

Status: Completed

Conditions: Non-small Cell Lung Cancer

Treatments: Device: Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutter

Study type: Observational

Funder types: Industry

Identifiers

NCT02338583

ESC-14-003

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.