NCT00880945

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2009

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

April 14, 2009

Status Verified

April 1, 2009

Enrollment Period

11 months

First QC Date

April 13, 2009

Last Update Submit

April 13, 2009

Conditions

Lung CancerSecondary Lung CancerBenign Lung Lesions

Keywords

FBScoin lesionsENBROSE

Outcome Measures

Primary Outcomes (1)

  • To evaluate the percentages of diagnosis that can be obtained adding ENB to conventional bronchoscopy in the same patient

    1 year

Study Arms (1)

36-40 patients

patients with small peripheral lesions who need bronchoscopy for diagnostic purposes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • patient with metastatic disease
  • patients unfit for surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

azienda ospedaliera -universitaria Maggiore della carità

Novara, novara, Italy

Location

MeSH Terms

Conditions

Lung NeoplasmsSolitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • piero em balbo, MD

    UOA PNEUMOLOGIA NOVARA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 14, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

April 14, 2009

Record last verified: 2009-04

Locations

IT(1)