Assessment of Video Assisted Thoracoscopic Surgery (VATS)... | NCT00912366

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

NCT00912366

Sponsor

Medtronic - MITG

Status

Terminated

Last Update Posted

Jul 27, 2015Estimated

Enrollment

39Actual

Phase

Not provided

Conditions

Non Small Cell Lung Cancer

Interventions

Lobectomy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow Enrollment

Expanded Access Info

Start Date

May 2009

Primary Completion Date

May 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jun 1, 2009

First Submission Date that Met QC Criteria

Jun 2, 2009

First Posted Date

Jun 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2015

Last Update Posted Date

Jul 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		VATS	Procedure: Lobectomy
Group B		Open Surgery	Procedure: Lobectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lobectomy	Procedure	Assessment of VATS versus open surgery.	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess hospital length of stay (LOS).		1 time point (discharge)
Pain Scale Evaluation		5 time points out to 6 months

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects referred for lobectomies at the hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D038481	Anterior Temporal Lobectomy

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative
D019635	Neurosurgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided