Powered Echelon Device in VATS Surgery

Ethicon

Status: Completed

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Device: Endocutter

Study type: Observational

Funder types: Industry

Identifiers

NCT01843192

ESC-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).

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suspected or confirmed NSCLC (up to and including Stage II)
• 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

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)
• Pregnancy
• Physical or psychological condition which would impair study participation;
• The patient is judged unsuitable for study participation by the Investigator for any other reason; or
• Unable or unwilling to attend follow-up visits and examinations

Trial design

71 participants in 1 patient group

VATS for suspected or confirmed NSCLC

Description:

Single arm study

Treatment:

Device: Endocutter