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

Ethicon Endo-Surgery3 sites in 1 country95 target enrollmentDecember 1, 2014

ConditionsNon-small Cell Lung Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Non-small Cell Lung Cancer
Sponsor: Ethicon Endo-Surgery
Enrollment: 95
Locations: 3
Primary Endpoint: Occurrence of prolonged air leaks
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2014

End Date

May 1, 2015

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ethicon Endo-Surgery

Responsible Party

Sponsor

Eligibility Criteria

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.