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| Name | Class |
|---|---|
| The eNose Company | INDUSTRY |
| Foundation for Research in Mycobacteria (FUNDAIM) | OTHER |
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The purpose of this study is to determine the diagnostic utility of the device 'Electronic Nose' for Pleural TB, which is a Extra pulmonary TB form, compared with pleural biopsy, the current gold standard.
The aim of the study is to determine the diagnostic utility of the device 'Electronic Nose' for Pleural TB, which is a Extra pulmonary TB form.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pleural TB | Experimental | This group consist of patients with TB pleural effusion. Intervention:
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| Control | Active Comparator | Patients with pleural effusion with different aetiologies than Tuberculosis. Intervention:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical History | Other | Oriented Survey and complete physical exam. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effects related to the use of the device, according to the CTCEA | 1 year |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergio Poli, MD | Contact | +584265172608 | sergio.polid@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jacobuss de Waard, PhD. | Instituto de Biomedicina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Biomedicina | Recruiting | Caracas | DC | 1020 | Venezuela |
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| ID | Term |
|---|---|
| D014396 | Tuberculosis, Pleural |
| ID | Term |
|---|---|
| D000092225 | Tuberculosis, Extrapulmonary |
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
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| ID | Term |
|---|---|
| D055991 | Health Records, Personal |
| D062609 | Electronic Nose |
| ID | Term |
|---|---|
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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| E-Nose |
| Device |
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 | Other |
|
| Pleural Fluid Analysis | Other | Cytomorphology Cytochemistry Adenosine Deaminase Value |
|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 |
| Investigative Techniques |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D055615 | Electrical Equipment and Supplies |