Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-01-31
2017-12-31
Brief Summary
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Detailed Description
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The patient who qualified for the study, according to the inclusion criteria, after consenting, will be guided through and oriented survey for risk factors, then a complete physical exam, and after that, the patient will breathe for 5 minutes trough the device, which stores the patient information, that later will be download to a computer and will be send to the server's manufacturer company, in Netherlands.
During and after the use of the device, investigators determine the adverse effects of the intervention, according to the CTCEA.
Investigators use the pleural biopsy, which is the gold standard, to determine the diagnostic utility of the test. And, will compare the results with other tests currently perform as the regular diagnostic routine, such as Chest CT, adenosine deaminase value of pleural fluid and cytomorphologic \& cytochemistry of the pleural fluid.
Patient Registries will be keep in an electronic database, as well as handwriting history, with the backup copy in the records of the hospital in which the patient was admitted.
Auditories will be realised by the Ethics Committee in different time frames.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Pleural TB
This group consist of patients with TB pleural effusion.
Intervention:
1. Inform Consent
2. Medical History
3. E-Nose Device
4. Chest CT
5. Cytomorphologic \& Cytochemistry of pleural Fluid.
6. Adenosine Deaminase value of pleural Fluid.
Medical History
Oriented Survey and complete physical exam.
E-Nose
Patient will breath trough the device for 5 minutes, and during and after the intervention will be assessed for adverse effects related to the use of the e-Nose, according to the CTCEA
Chest CT
Pleural Fluid Analysis
Cytomorphology Cytochemistry Adenosine Deaminase Value
Control
Patients with pleural effusion with different aetiologies than Tuberculosis.
Intervention:
1. Inform Consent
2. Medical History
3. E-Nose Device
4. Chest CT
5. Cytomorphologic \& Cytochemistry of pleural Fluid.
6. Adenosine Deaminase value of pleural Fluid.
Medical History
Oriented Survey and complete physical exam.
E-Nose
Patient will breath trough the device for 5 minutes, and during and after the intervention will be assessed for adverse effects related to the use of the e-Nose, according to the CTCEA
Chest CT
Pleural Fluid Analysis
Cytomorphology Cytochemistry Adenosine Deaminase Value
Interventions
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Medical History
Oriented Survey and complete physical exam.
E-Nose
Patient will breath trough the device for 5 minutes, and during and after the intervention will be assessed for adverse effects related to the use of the e-Nose, according to the CTCEA
Chest CT
Pleural Fluid Analysis
Cytomorphology Cytochemistry Adenosine Deaminase Value
Eligibility Criteria
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Inclusion Criteria
2. More than 15 years old.
3. Pleural effusion of any etiology
Exclusion Criteria
2. Not capable to exhaled through the E-nose.
3. No possibility to follow-up.
4. By discretion of the research team.
15 Years
ALL
Yes
Sponsors
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The ENose Company, Zutphen, Netherlands
UNKNOWN
Foundation for Research in Mycobacteria (FUNDAIM)
OTHER
Universidad Central de Venezuela
OTHER
Responsible Party
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Jacobus H. de Waard
Chief of Tuberculosis Laboratory
Principal Investigators
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Jacobuss de Waard, PhD.
Role: PRINCIPAL_INVESTIGATOR
Instituto de Biomedicina
Locations
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Instituto de Biomedicina
Caracas, DC, Venezuela
Countries
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Central Contacts
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Facility Contacts
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Sergio Poli, MD
Role: primary
Other Identifiers
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EN002
Identifier Type: -
Identifier Source: org_study_id