eNose-TB: Electronic Nose for Tuberculosis Screening

  • STATUS
    Recruiting
  • days left to enroll
    27
  • participants needed
    1778
  • sponsor
    Gadjah Mada University
Updated on 22 April 2022
Accepts healthy volunteers

Summary

An electronic-nose (e-nose) had been investigated as a diagnostic tool for tuberculosis by examining exhaled breath of the patients. Universitas Gadjah Mada has developed an e-nose device for TB diagnostic tool. Here the investigators test the device in order to analyze the sensitivity and specificity electronic-nose as a screening tool for tuberculosis.

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.

Details
Condition Tuberculosis
Treatment exhaled breath sampling
Clinical Study IdentifierNCT04567498
SponsorGadjah Mada University
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Validation Phase (Group 1)
Suspected of having TB
Screening Phase (Group 2)
Adult and children
Able to produce samples for Xpert MTB/Rif examination
Adult and children
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
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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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