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Assessment of Video Assisted Thoracoscopic Surgery (VATS) Versus Open Surgery for Patients Undergoing Lobectomy
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
1 other identifier
observational
39
1 country
1
Brief Summary
Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 1, 2009
CompletedFirst Posted
Study publicly available on registry
June 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 27, 2015
July 1, 2015
1 year
June 1, 2009
July 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Assess hospital length of stay (LOS).
1 time point (discharge)
Pain Scale Evaluation
5 time points out to 6 months
Secondary Outcomes (2)
Assess quality of life.
2 time points out to 6 months
Assess peri-operative and post-operative complications.
5 time points out to 6 months.
Study Arms (2)
Group A
VATS
Group B
Open Surgery
Interventions
Eligibility Criteria
Subjects referred for lobectomies at the hospital.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2009
First Posted
June 3, 2009
Study Start
May 1, 2009
Primary Completion
May 1, 2010
Study Completion
December 1, 2010
Last Updated
July 27, 2015
Record last verified: 2015-07