Powered Surgical Stapler in VATS Lung Resection Procedures in China

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338583
• Other study ID #: ESC-14-003
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: August 10, 2017
• Start date: December 1, 2014
• Est. completion date: May 1, 2015

Study information

• Verified date: August 2017
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: May 1, 2015
• Est. primary completion date: April 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Cancer Institute & Hospital, Chinese Academy of Medical Sciences	Beijing
China	Wuhan Tongji Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of prolonged air leaks		30 days
Secondary	2.Occurrence of postoperative air leaks		30 days
Secondary	Length of stay (LOS)		30 days
Secondary	Volume of estimated intra-operative blood loss		Intra-operative
Secondary	5.Time to chest tube removal		30 days