Overview

This trial is active, not recruiting.

Condition tuberculosis, pleural
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
This group consist of patients with TB pleural effusion. Intervention: Inform Consent Medical History E-Nose Device Chest CT Cytomorphologic & Cytochemistry of pleural Fluid. 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
(Active Comparator)
Patients with pleural effusion with different aetiologies than Tuberculosis. Intervention: Inform Consent Medical History E-Nose Device Chest CT Cytomorphologic & Cytochemistry of pleural Fluid. 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

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universidad Central de Venezuela.