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

This study has been terminated.
(Slow Enrollment)
Information provided by (Responsible Party):
Medtronic - MITG Identifier:
First received: June 1, 2009
Last updated: July 23, 2015
Last verified: July 2015
Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.

Condition Intervention
Non Small Cell Lung Cancer
Procedure: Lobectomy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • Assess hospital length of stay (LOS). [ Time Frame: 1 time point (discharge) ] [ Designated as safety issue: No ]
  • Pain Scale Evaluation [ Time Frame: 5 time points out to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess quality of life. [ Time Frame: 2 time points out to 6 months ] [ Designated as safety issue: No ]
  • Assess peri-operative and post-operative complications. [ Time Frame: 5 time points out to 6 months. ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
Procedure: Lobectomy
Assessment of VATS versus open surgery.
Other Names:
Group B
Open Surgery
Procedure: Lobectomy
Assessment of VATS versus open surgery.
Other Names:


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects referred for lobectomies at the hospital.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00912366

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 Identifier: NCT00912366     History of Changes
Other Study ID Numbers: AS08015 
Study First Received: June 1, 2009
Last Updated: July 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic - MITG:
Lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on May 25, 2016