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NCT00880945 Clinical Trial

Conventional Bronchoscopy Plus Rose Versus Electromagnetic Navigation (EMN) Plus Rose in Small Peripheral Lesions

Lung Cancer Clinical Trial

Official title:
Comparison of the Electromagnetic Navigation System and Rapid on Site Evaluation Versus Conventional Bronchoscopy and Rapid on Site Evaluation: Improved Yield in Small Peripheral Lung Lesions(Original Investigation)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00880945
Other study ID # 2010-no-emn
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 13, 2009
Last updated April 13, 2009
Start date May 2009
Est. completion date May 2010

Study information
Verified date April 2009
Source Azienda Ospedaliero Universitaria Maggiore della Carita
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate if Electromagnetic navigation (ENB) in combination with rapid on site evaluation (ROSE) can improve diagnostic accuracy in those patients who fail to be diagnosed with conventional fluoroscopic assisted bronchoscopy (FBS) in combination with ROSE.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date May 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- presence of small peripheral lung lesions (< 3 cm) in patient suitable for surgical procedure

Exclusion Criteria:

- patient with metastatic disease

- patients unfit for surgical procedure

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Italy azienda ospedaliera -universitaria Maggiore della carità Novara

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the percentages of diagnosis that can be obtained adding ENB to conventional bronchoscopy in the same patient 1 year No
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