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Powered Echelon Device in VATS Surgery

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ClinicalTrials.gov Identifier: NCT01808430
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery (Europe) GmbH

Brief Summary:
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).

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer (NSCLC) Procedure: VATS for confirmed non-small cell lung cancer (NSCLC)

Detailed 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).

Study Type : Observational [Patient Registry]
Actual Enrollment : 158 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Weeks
Official Title: Real World Outcomes of Video-Assisted Thoracoscopic Surgery for Lung Cancer Using ECHELON FLEX™ Powered ENDOPATH® Stapler: a Prospective European Multicenter Study
Study Start Date : March 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
VATS for NSCLC patients
VATS for confirmed non-small cell lung cancer (NSCLC)
Procedure: VATS for confirmed non-small cell lung cancer (NSCLC)
Video-Assisted Thoracoscopic Surgery for NSCLC patients
Other Name: Video-Assisted Thoracoscopic Surgery




Primary Outcome Measures :
  1. occurrence and duration of post-operative air leak [ Time Frame: prolonged air leak defined as longer than 5 days post-op ]
    occurrence and duration of prolonged air leak defined as longer than 5 days


Secondary Outcome Measures :
  1. volume of estimated intra-operative blood loss [ Time Frame: blood loss intra-op and up to 5 days post-op ]
    volume of estimated intra-operative blood loss



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808430


Locations
Denmark
Professor Peter Licht
Odense, Denmark, 5000
Sponsors and Collaborators
Ethicon Endo-Surgery (Europe) GmbH
Investigators
Study Chair: Goran Ribaric, MD, MSc, PhD Ethicon Endo-Surgery (Europe) GmbH

Responsible Party: Ethicon Endo-Surgery (Europe) GmbH
ClinicalTrials.gov Identifier: NCT01808430     History of Changes
Other Study ID Numbers: CME-12-001
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Ethicon Endo-Surgery (Europe) GmbH:
NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms