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

NCT ID: NCT00912366

Last Updated: 2015-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

VATS

Lobectomy

Intervention Type PROCEDURE

Assessment of VATS versus open surgery.

Group B

Open Surgery

Lobectomy

Intervention Type PROCEDURE

Assessment of VATS versus open surgery.

Interventions

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Lobectomy

Assessment of VATS versus open surgery.

Intervention Type PROCEDURE

Other Intervention Names

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CVATS HVATS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AS08015

Identifier Type: -

Identifier Source: org_study_id

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