E-Nose: Diagnostic Tool for Pleural TB
This trial is active, not recruiting.
|Treatments||medical history, e-nose, chest ct, pleural fluid analysis|
|Sponsor||Universidad Central de Venezuela|
|Collaborator||The ENose Company, Zutphen, Netherlands|
|Start date||January 2015|
|End date||September 2016|
|Trial size||100 participants|
|Trial identifier||NCT02765087, EN002|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion
time frame: 1 year
Adverse Effects related to the use of the device, according to the CTCEA
time frame: 1 year
Male or female participants at least 15 years old.
Inclusion Criteria 1. Accept to participate in the study through a signed informed consent approved by the Ethical Committee of our Institution. 2. More than 15 years old. 3. Pleural effusion of any etiology Exclusion Criteria: 1. Severe compromise of the general condition 2. Not capable to exhaled through the E-nose. 3. No possibility to follow-up. 4. By discretion of the research team.
|Official title||Diagnostic Utility of the E-Nose for Pleural TB|
|Principal investigator||Jacobuss de Waard, PhD.|
|Description||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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