Tuberculosis, PleuralNCT02765087
E-Nose: Diagnostic Tool for Pleural TB
A study testing Medical History, E-Nose and Chest CT in people with Tuberculosis, Pleural, run by Universidad Central de Venezuela at 1 site in Venezuela.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Pleural
- What is being tested?
- Medical History, E-Nose and Chest CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteVenezuela
- Study dates
- Jan 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Venezuela1 site, 1 recruiting
- Recruiting
Instituto de Biomedicina
Caracas, DC, 1020
Sergio Poli, MD, +584265172608, sergio.polid@gmail.com
Jacobus de Waard, PhD.
About this study
Official title: Diagnostic Utility of the E-Nose for Pleural TB
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.
Read the 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.
- Conditions
- Tuberculosis, Pleural
- Being tested
- Medical History, E-Nose, Chest CT, Pleural Fluid Analysis
- Medical subject headings
- Tuberculosis, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical HistoryOther
Oriented Survey and complete physical exam.
E-NoseDevice
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 CTOther
Pleural Fluid AnalysisOther
Cytomorphology Cytochemistry Adenosine Deaminase Value
| Study group | Role | What they receive |
|---|---|---|
| Pleural TB | Experimental | This 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. Receives: Other: Medical History; Device: E-Nose; Other: Chest CT; Other: Pleural Fluid Analysis |
| Control | Active comparator | Patients 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. Receives: Other: Medical History; Device: E-Nose; Other: Chest CT; Other: Pleural Fluid Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion
Measured: 1 year
Secondary outcomes (1)
Adverse Effects related to the use of the device, according to the CTCEA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PleuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Central de Venezuela
- Sponsor type
- University, hospital or other
- Collaborators
- The eNose Company, Foundation for Research in Mycobacteria (FUNDAIM)
- Responsible party
- Principal investigator, Jacobus H. de Waard, Universidad Central de Venezuela
- Investigators
- Jacobuss de Waard, PhD., Principal investigator, Instituto de Biomedicina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765087
- Sponsor's protocol ID
- EN002
- Status last verified
- Nov 2017
- First submitted
- 4 May 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of the E-Nose for Pleural TB
- ClinicalTrials.gov ID
- NCT02765087
- Acronym / sponsor ID
- EN002
- Conditions
- Tuberculosis, Pleural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Central de VenezuelaUniversity, hospital or other
- Collaborators
- The eNose Company, Foundation for Research in Mycobacteria (FUNDAIM)
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pleural TB | Experimental | Other: Medical History, Device: E-Nose, Other: Chest CT, Other: Pleural Fluid AnalysisThis 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 comparator | Other: Medical History, Device: E-Nose, Other: Chest CT, Other: Pleural Fluid AnalysisPatients 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical HistoryOriented Survey and complete physical exam. | Other | Control, Pleural TB |
| E-NosePatient 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 | Device | Control, Pleural TB |
| Chest CT | Other | Control, Pleural TB |
| Pleural Fluid AnalysisCytomorphology Cytochemistry Adenosine Deaminase Value | Other | Control, Pleural TB |
Primary outcome
Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion
Time frame: 1 year
1 secondary outcome
Adverse Effects related to the use of the device, according to the CTCEA
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacobuss de Waard, PhD. principal investigator
Instituto de Biomedicina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical History, E-Nose and Chest CT in people with Tuberculosis, Pleural, run by Universidad Central de Venezuela at 1 site in Venezuela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio Poli, MD (+584265172608, sergio.polid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017; AzTrials last refreshed its copy on 27 Oct 2026.