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

This study is not yet open for participant recruitment.

Verified by Azienda Ospedaliero Universitaria Maggiore della Carita, April 2009

First Received: April 13, 2009 No Changes Posted

Sponsored by:	Azienda Ospedaliero Universitaria Maggiore della Carita
Information provided by:	Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:	NCT00880945

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

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, 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)

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
novara, Italy

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

Keywords provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

FBS
coin lesions
ENB
ROSE

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on May 07, 2009