E-Nose: Diagnostic Tool for Pleural TB
Primary Purpose
Tuberculosis, Pleural
Status
Unknown status
Phase
Not Applicable
Locations
Venezuela
Study Type
Interventional
Intervention
Medical History
E-Nose
Chest CT
Pleural Fluid Analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis, Pleural
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Instituto de BiomedicinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pleural TB
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion
Secondary Outcome Measures
Adverse Effects related to the use of the device, according to the CTCEA
Full Information
NCT ID
NCT02765087
First Posted
May 4, 2016
Last Updated
November 12, 2017
Sponsor
Universidad Central de Venezuela
Collaborators
The ENose Company, Zutphen, Netherlands, Foundation for Research in Mycobacteria (FUNDAIM)
1. Study Identification
Unique Protocol Identification Number
NCT02765087
Brief Title
E-Nose: Diagnostic Tool for Pleural TB
Official Title
Diagnostic Utility of the E-Nose for Pleural TB
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Central de Venezuela
Collaborators
The ENose Company, Zutphen, Netherlands, Foundation for Research in Mycobacteria (FUNDAIM)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pleural
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pleural TB
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Medical History
Intervention Description
Oriented Survey and complete physical exam.
Intervention Type
Device
Intervention Name(s)
E-Nose
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Chest CT
Intervention Type
Other
Intervention Name(s)
Pleural Fluid Analysis
Intervention Description
Cytomorphology Cytochemistry Adenosine Deaminase Value
Primary Outcome Measure Information:
Title
Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse Effects related to the use of the device, according to the CTCEA
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio Poli, MD
Phone
+584265172608
Email
sergio.polid@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacobuss de Waard, PhD.
Organizational Affiliation
Instituto de Biomedicina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Biomedicina
City
Caracas
State/Province
DC
ZIP/Postal Code
1020
Country
Venezuela
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Poli, MD
Phone
+584265172608
Email
sergio.polid@gmail.com
First Name & Middle Initial & Last Name & Degree
Jacobus de Waard, PhD.
First Name & Middle Initial & Last Name & Degree
Luisa Quesada, MD
First Name & Middle Initial & Last Name & Degree
Sergio Poli, MD
First Name & Middle Initial & Last Name & Degree
Emines Salas, BsBio
First Name & Middle Initial & Last Name & Degree
Fernando Poli, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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E-Nose: Diagnostic Tool for Pleural TB
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