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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Azienda Ospedaliero Universitaria Maggiore della Carita.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:
NCT00880945
First received: April 13, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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
Lung Cancer
Secondary Lung Cancer
Benign Lung Lesions

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • To evaluate the percentages of diagnosis that can be obtained adding ENB to conventional bronchoscopy in the same patient [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
36-40 patients
patients with small peripheral lesions who need bronchoscopy for diagnostic purposes

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Balbo Piero, UOA pneumologia
ClinicalTrials.gov Identifier: NCT00880945     History of Changes
Other Study ID Numbers: 2010-no-emn
Study First Received: April 13, 2009
Last Updated: April 13, 2009
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013