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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


N/A
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Assess hospital length of stay (LOS).

Outcome Time Frame:

1 time point (discharge)

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

AS08015

NCT ID:

NCT00912366

Start Date:

May 2009

Completion Date:

November 2011

Related Keywords:

  • Non Small Cell Lung Cancer
  • VATS
  • Lung cancer
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

New York University School of Medicine New York, New York  10016