Powered Surgical Stapler in VATS Lung Resection Procedures in China

NCT02338583 | Completed FDA Device

• 1 other identifier: ESC-14-003
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of prolonged air leaks

  30 days

Secondary Outcomes (4)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals scheduled for VATS lobectomy or diagnostic VATS wedge resection in accordance with their institution's SOC

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (3)

Beijing Cancer Hospital

Beijing, China

Location

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Wuhan Tongji Hospital

Beijing, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 14, 2015
• Study Start: December 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)