E-Nose: Diagnostic Tool for Pleural TB

Tuberculosis, Pleural Clinical Trial

Official title:

Diagnostic Utility of the E-Nose for Pleural TB

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02765087
• Other study ID #: EN002
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2016
• Last updated: November 12, 2017
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2017
• Source: Universidad Central de Venezuela
• Contact: Sergio Poli, MD
• Phone: +584265172608
• Email: sergio.polid[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pleural

Intervention

Other:
• Medical History
Oriented Survey and complete physical exam.

Device:
• 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

Other:
• Chest CT

• Pleural Fluid Analysis
Cytomorphology Cytochemistry Adenosine Deaminase Value

Locations

Country	Name	City	State
Venezuela	Instituto de Biomedicina	Caracas	DC

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Central de Venezuela	Fundación Para la Investigación en Micobacterias (FUNDAIM), The ENose Company, Zutphen, Netherlands

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion		1 year
Secondary	Adverse Effects related to the use of the device, according to the CTCEA		1 year