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NCT02219945 Clinical Trial

ENOSE in Pulmonary Tuberculosis in Yogyakarta

Other Specified Chronic Obstructive Pulmonary Disease Clinical Trial

— YOGYATBNOSE  

Official title:
The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02219945
Other study ID # TBDIAGNOSE
Secondary ID KE/FK/859/EC
Status Completed
Phase N/A
First received August 1, 2014
Last updated May 31, 2017
Start date November 2013
Est. completion date April 2017

Study information
Verified date May 2017
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Study participants provide WIC and after time for consideration, when they approve, provide demographic anonymized data.

The study population consists of six groups:

Group 1 - 20 TB patients aged > 18 yrs Group 2 - 20 non--‐TB patients > 18 yrs (screened for TB - other conditions) Group 3 - 20 patients with a lung disease - no TB suspects (Lung Clinics in Yogyakarta,Indonesia; Group 4 - 50 apparently healthy matched controls Group 5 - 20 newly diagnosed TB patients enrolled before start of treatment, to be followed over time, until after end of treatment (8 months FU).

Group 6 - 50 apparently healthy volunteers.

Study participants breath normally by mouthpiece into the device using a nose clamp - for 5 min during each sampling.

Electronic data are downloaded and transmitted by internet to Zutphen, Netherlands where data are processed to build the model.

Recruitment information / eligibility
Status Completed
Enrollment 389
Est. completion date April 2017
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age >18yrs

- voluntarily participating

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Indonesia patients - at 5 lung clinics (Minggiran, Kalasan, Kotagede, Bantul, Kuonprogo) connected with Sudjarto Teachnig Hospital; healthy controls among students and staff of Hospital and Gadjah Mada Universitas Yogyakarta Jalan Kesehatan no.1, Yogyakarta

Sponsors (3)
Lead Sponsor Collaborator
Tjip van der Werf Gadjah Mada University, The Enose Company, Zutphen the Netherlands

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnostic precision of electronic nose signal in pulmonary TB sensitivity and specificity of electronic nose signal in diagnosing and measuring response to treatment in pulmonary TB 18 months
Secondary measuring response to TB treatment over time with the electronic nose cohort of patients newly deteted with PTB will be followed with the enose device over time to monitor disease activity, until end of treatment 18 months