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

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ClinicalTrials.gov Identifier: NCT00880945
Recruitment Status : Unknown
Verified April 2009 by Azienda Ospedaliero Universitaria Maggiore della Carita.
Recruitment status was:  Not yet recruiting
First Posted : April 14, 2009
Last Update Posted : April 14, 2009
Sponsor:
Information provided by:
Azienda Ospedaliero Universitaria Maggiore della Carita

Brief 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.

Condition or disease
Lung Cancer Secondary Lung Cancer Benign Lung Lesions

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
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)
Study Start Date : May 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
36-40 patients
patients with small peripheral lesions who need bronchoscopy for diagnostic purposes



Primary Outcome Measures :
  1. To evaluate the percentages of diagnosis that can be obtained adding ENB to conventional bronchoscopy in the same patient [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with peripheral lesion suitable for surgery who need preoperative diagnosis will be studied, at first, with conventional bronchoscopy under fluoroscopic guidance. In case of non diagnostic procedure they will be candidates for ENB. All the patients will be candidates to surgical procedure in case of malignant lesions.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880945


Locations
Italy
azienda ospedaliera -universitaria Maggiore della carità Not yet recruiting
Novara, Italy
Contact: piero em balbo, md    00393213733445    piero.balbo@libero.it   
Principal Investigator: piero em balbo, MD         
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
Principal Investigator: piero em balbo, MD UOA PNEUMOLOGIA NOVARA

Responsible Party: Balbo Piero, UOA pneumologia
ClinicalTrials.gov Identifier: NCT00880945     History of Changes
Other Study ID Numbers: 2010-no-emn
First Posted: April 14, 2009    Key Record Dates
Last Update Posted: April 14, 2009
Last Verified: April 2009

Keywords provided by Azienda Ospedaliero Universitaria Maggiore della Carita:
FBS
coin lesions
ENB
ROSE

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases