Powered Echelon Device in VATS Surgery

Ethicon

Status: Completed

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Procedure: VATS for confirmed non-small cell lung cancer (NSCLC)

Study type: Observational

Funder types: Industry

Identifiers

NCT01808430

CME-12-001

Details and patient eligibility

About

This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).

Full description

The European prospective observational multi-center cohort study aims to collect real-world outcomes of consecutive patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lung Cancer (NSCLC) or scheduled for VATS wedge resection for undiagnosed pulmonary nodule or metastasis from colorectal cancer (CRC) in accordance with their institution's Standard-of-care (SOC).

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed NSCLC (up to and including Stage II) for patients undergoing VATS lobectomy. For patients undergoing wedge resection for undiagnosed pulmonary nodule or metastasis from CRC, a malignant diagnosis may be confirmed post-operatively.
• Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung
• Willing to give consent and comply with evaluation and treatment schedule
• At least 18 years of age

Exclusion criteria

• Active bacterial infection or fungal infection
• Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure)
• Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure
• Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
• Prior history of VATS or open lung surgery

Trial design

158 participants in 1 patient group

VATS for NSCLC patients

Description:

VATS for confirmed non-small cell lung cancer (NSCLC)

Treatment:

Procedure: VATS for confirmed non-small cell lung cancer (NSCLC)