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Non-invasive TB Triage and Patient Mapping Platform Using Breath Via Low-Cost Titanium Dioxide Nanotube Sensor

NCT02681445 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 810

Last updated 2018-02-01

No results posted yet for this study

Summary

The purpose of this pilot study is to evaluate the sensitivity and specificity of a nanotube-based point-of-care breath-based tuberculosis screening test as compared to the current standards of care including sputum microscopy, sputum culture, chest X-ray, and GeneXpert (MTB/RIF).

The primary objective is to determine an initial estimate of the sensitivity and specificity of a nano-tube based point-of-care test for the diagnosis and screening of active pulmonary tuberculosis.

Secondary objectives include the collection of user data to test and further develop the screening platform based on end-user feedback.

Conditions

Interventions

DEVICE

Breath Collection

breath will be collected from patients in breath bag for analysis for observational study.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • India

Study Locations

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Entities

Diseases
Companies

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 NCT02681445 on ClinicalTrials.gov