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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02219945
Date of registration: 01/08/2014
Prospective Registration: No
Primary sponsor: Tjip van der Werf
Public title: ENOSE in Pulmonary Tuberculosis in Yogyakarta YOGYATBNOSE
Scientific title: The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients
Date of first enrolment: November 2013
Target sample size: 389
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02219945
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Indonesia
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- age >18yrs

- voluntarily participating

Exclusion Criteria:



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Other Specified Chronic Obstructive Pulmonary Disease
Pulmonary Tuberculosis Suspected
Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology
Intervention(s)
Other: 5 min exhaled breath sampling with soft nose clamp
Primary Outcome(s)
diagnostic precision of electronic nose signal in pulmonary TB [Time Frame: 18 months]
Secondary Outcome(s)
measuring response to TB treatment over time with the electronic nose [Time Frame: 18 months]
Secondary ID(s)
TBDIAGNOSE
KE/FK/859/EC
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
The Enose Company, Zutphen the Netherlands
Gadjah Mada University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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