Powered Echelon Device in VATS Surgery

NCT ID: NCT01808430

Last Updated: 2015-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

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).

Detailed Description

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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).

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 NSCLC patients

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

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

Intervention Type PROCEDURE

Video-Assisted Thoracoscopic Surgery for NSCLC patients

Interventions

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

Video-Assisted Thoracoscopic Surgery for NSCLC patients

Intervention Type PROCEDURE

Other Intervention Names

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Video-Assisted Thoracoscopic Surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery (Europe) GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Goran Ribaric, MD, MSc, PhD

Role: STUDY_CHAIR

Ethicon Endo-Surgery (Europe) GmbH

Locations

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Professor Peter Licht

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CME-12-001

Identifier Type: -

Identifier Source: org_study_id

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