Powered Echelon Device in VATS Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer (NSCLC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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VATS for suspected or confirmed NSCLC

Single arm study

Endocutter

Intervention Type DEVICE

Interventions

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Endocutter

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No