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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00912366
• Other study ID #: AS08015
• Status: Terminated
• Phase: N/A
• First received: June 1, 2009
• Last updated: July 23, 2015
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2015
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Procedure:
• Lobectomy
Assessment of VATS versus open surgery.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess hospital length of stay (LOS).		1 time point (discharge)	No
Primary	Pain Scale Evaluation		5 time points out to 6 months	No
Secondary	Assess quality of life.		2 time points out to 6 months	No
Secondary	Assess peri-operative and post-operative complications.		5 time points out to 6 months.	No