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Assessment of Video Assisted Thoracoscopic Surgery (VATS) Versus Open Surgery for Patients Undergoing Lobectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00912366
Recruitment Status : Terminated (Slow Enrollment)
First Posted : June 3, 2009
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Procedure: Lobectomy

Study Design

Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Single Center, Observational Study Comparing the Safety and Efficacy of CVATS, HVATS and Open Surgery for Subjects Diagnosed With NSCLC Scheduled to Undergo a Lobectomy
Study Start Date : May 2009
Primary Completion Date : May 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Group A
VATS
Procedure: Lobectomy
Assessment of VATS versus open surgery.
Other Names:
  • CVATS
  • HVATS
Group B
Open Surgery
Procedure: Lobectomy
Assessment of VATS versus open surgery.
Other Names:
  • CVATS
  • HVATS


Outcome Measures

Primary Outcome Measures :
  1. Assess hospital length of stay (LOS). [ Time Frame: 1 time point (discharge) ]
  2. Pain Scale Evaluation [ Time Frame: 5 time points out to 6 months ]

Secondary Outcome Measures :
  1. Assess quality of life. [ Time Frame: 2 time points out to 6 months ]
  2. Assess peri-operative and post-operative complications. [ Time Frame: 5 time points out to 6 months. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects referred for lobectomies at the hospital.
Criteria

Inclusion Criteria:

  • Subject must be 18 years of age or older.
  • Subject must have been clinically diagnosed with stage I to stage IIA non small cell lung cancer measuring and judged to be resectable.
  • Subject must be able to tolerate general anesthesia, and have cardiopulmonary reserve to tolerate a lobectomy

Exclusion Criteria:

  • Subject is pregnant (documented by pregnancy test) or breastfeeding.
  • Subject has other severe illnesses that would preclude surgery such as

    • Unstable angina
    • Myocardial Infarction within 3 months
    • Coronary Artery Bypass Graft Surgery
  • Subject has other active cancers
  • Subject is unable to comply with any of the following:

    • Study requirements
    • Give valid informed consent
    • Follow-up schedule
Contacts and Locations

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): NCT00912366


Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Medtronic - MITG
More Information

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00912366     History of Changes
Other Study ID Numbers: AS08015
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015

Keywords provided by Medtronic - MITG:
VATS
Lung cancer
NSCLC

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