E-Nose: Diagnostic Tool for Pleural TB

Diagnostic Utility of the E-Nose for Pleural TB

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02765087

Enrollment

100

Registered

2016-05-06

Start date

2015-01-31

Completion date

2017-12-31

Last updated

2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis, Pleural

Brief summary

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.

Detailed 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.

Interventions

OTHERMedical History

Oriented Survey and complete physical exam.

DEVICEE-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

OTHERChest CT

OTHERPleural Fluid Analysis

Cytomorphology Cytochemistry Adenosine Deaminase Value

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion	1 year

Secondary

Measure	Time frame
Adverse Effects related to the use of the device, according to the CTCEA	1 year

Countries

Venezuela

Contacts

Primary ContactSergio Poli, MD

sergio.polid@gmail.com+584265172608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026