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ENOSE in Pulmonary Tuberculosis in Yogyakarta

NCT02219945 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2017-06-01

No results posted yet for this study

Summary

Electronic noses detecting patterns of volatile molecules have recently been introduced for different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%. Here the investigators test a production type point-of-care hand-held device with less detectors. The investigators explore factors such as food intake, smoking, and co-morbidity, as well as the impact of TB treatment, and address the question whether the device could help monitor disease and response to treatment.

Conditions

  • Pulmonary Tuberculosis Suspected
  • Other Specified Chronic Obstructive Pulmonary Disease
  • Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology

Interventions

OTHER

5 min exhaled breath sampling with soft nose clamp

study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc

Sponsors & Collaborators

  • Gadjah Mada University

    collaborator OTHER

  • The Enose Company, Zutphen the Netherlands

    collaborator UNKNOWN

  • Tjip van der Werf

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-12-31
Completion
2017-04-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02219945 on ClinicalTrials.gov