Powered Surgical Stapler in VATS Lung Resection Procedures in China

NCT ID: NCT02338583

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 95 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-01
• Study Completion Date: 2015-05-01

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, , China

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Wuhan Tongji Hospital

Beijing, , China

Countries

China

Other Identifiers

ESC-14-003

Identifier Type: -

Identifier Source: org_study_id