E-Nose: Diagnostic Tool for Pleural TB
Diagnostic Utility of the E-Nose for Pleural TB
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedNovember 14, 2017
November 1, 2017
2.9 years
May 4, 2016
November 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion
1 year
Secondary Outcomes (1)
Adverse Effects related to the use of the device, according to the CTCEA
1 year
Study Arms (2)
Pleural TB
EXPERIMENTALThis group consist of patients with TB pleural effusion. Intervention: 1. Inform Consent 2. Medical History 3. E-Nose Device 4. Chest CT 5. Cytomorphologic \& Cytochemistry of pleural Fluid. 6. Adenosine Deaminase value of pleural Fluid.
Control
ACTIVE COMPARATORPatients with pleural effusion with different aetiologies than Tuberculosis. Intervention: 1. Inform Consent 2. Medical History 3. E-Nose Device 4. Chest CT 5. Cytomorphologic \& Cytochemistry of pleural Fluid. 6. Adenosine Deaminase value of pleural Fluid.
Interventions
Eligibility Criteria
You may qualify if:
- Accept to participate in the study through a signed informed consent approved by the Ethical Committee of our Institution.
- More than 15 years old.
- Pleural effusion of any etiology
You may not qualify if:
- Severe compromise of the general condition
- Not capable to exhaled through the E-nose.
- No possibility to follow-up.
- By discretion of the research team.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Biomedicina
Caracas, DC, 1020, Venezuela
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacobuss de Waard, PhD.
Instituto de Biomedicina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Tuberculosis Laboratory
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 6, 2016
Study Start
January 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
November 14, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share