- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04567498
eNose-TB: Electronic Nose for Tuberculosis Screening
eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia
Study Overview
Detailed Description
The study population consists of 2 groups:
Group 1 - presumptive TB patients. Group 2 - residents of area with high risk of TB.
Study participants provide written informed consent. The participants are asked to breathe normally using a mask for 2 times then inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full (two times). The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter protecting the e-nose from microbes. The breath pattern will be recorded in the e-nose device, which is connected to a laptop that will display the recorded breath pattern. Other data are collected: clinical symptoms, results of chest X-ray, smear microscopic, and Xpert MTB/Rif examinations.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Antonia Saktiawati, MD, PhD
- Phone Number: +6281227976434
- Email: a.morita@ugm.ac.id
Study Locations
-
-
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Yogyakarta, Indonesia
- Not yet recruiting
- Primary Health Centers
-
Contact:
- Suharna
- Phone Number: +628156898290
-
-
Central Java
-
Klaten, Central Java, Indonesia, 50131
- Recruiting
- Balai Kesehatan Masyarakat Klaten
-
Contact:
- Sigit Armunanto, dr., M.Kes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- Inclusion Criteria:
Validation Phase (Group 1):
- Adult and children
- Suspected of having TB
- Agree to participate in the study
- Able to produce exhaled air samples
- Able to produce samples for Xpert MTB/Rif examination
Screening Phase (Group 2):
- Adult and children
- Agree to participate in the study
- Able to produce exhaled air samples
Currently not in TB treatment
- Exclusion Criteria
- Invalid measurements of breath tests
- Incomplete CXR data
- Missing specimens
- Unable to breath normally for 2 minutes due to respiratory illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Presumptive TB patients (395 participants - adult and children)
The participants breathe normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full.
|
The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full.
The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter.
The data are read and stored in the e-nose machine.
Other Names:
|
Experimental: Residents of area with high risk of TB (1383 participants - adult and children)
The participants breathe normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full.
|
The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full.
The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter.
The data are read and stored in the e-nose machine.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
diagnostic accuracy of electronic nose signal in tuberculosis
Time Frame: 2 years
|
sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yodi Mahendradhata, MD, MSc, PhD, Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada
- Principal Investigator: Antonia Saktiawati, MD, PhD, Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 002/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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