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

April 13, 2009 updated by: Azienda Ospedaliero Universitaria Maggiore della Carita

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)

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy
        • azienda ospedaliera -universitaria Maggiore della carità
        • Contact:
        • Principal Investigator:
          • piero em balbo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

  • Principal Investigator: piero em balbo, MD, UOA PNEUMOLOGIA NOVARA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

April 13, 2009

First Submitted That Met QC Criteria

April 13, 2009

First Posted (Estimate)

April 14, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2009

Last Update Submitted That Met QC Criteria

April 13, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-no-emn

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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