Tuberculosis, Pulmonary Clinical Trial
Official title:
Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB
Verified date | May 2016 |
Source | Universidad Central de Venezuela |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in Venezuela.
Status | Active, not recruiting |
Enrollment | 250 |
Est. completion date | February 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria: - Accept to participate in the study through a signed informed consent approved by the Ethical Committee of our Institution. - More than 15 years old. - People with a culture positive for pulmonary TB Exclusion Criteria: - Severe compromise of the general condition. - Not capable to exhaled through the E-nose. - No possibility to follow-up. - By discretion of the research team. |
Country | Name | City | State |
---|---|---|---|
Venezuela | Instituto de Biomedicina | Caracas | DC |
Lead Sponsor | Collaborator |
---|---|
Universidad Central de Venezuela | Fundación Para la Investigación en Micobacterias (FUNDAIM), The ENose Company, Zutphen, Netherlands |
Venezuela,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic Accuracy of the electronic nose signal value to differentiate patients with Pulmonary TB. | Sensitivity, Specificity and Predictive Values; calculated with an ROC curve based on the Average processed-signal of the three electronic nose sensors. The signal is generated with a complex pattern recognition software, measuring the adsorption rate, desorption rate, and area under the curve generated by each sensor, expressed with a single value that ranges between -1 to +1. | 1 year | |
Primary | Average Days needed to observed a negative result with the device after initiation of treatment. | Days-to-negative. | 60 days | |
Secondary | Number of Adverse Effects related to the used of the device, assess by the CTCAE | 1 year |
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