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A study to clinically validate a novel microscopy device for tuberculosis diagnosis

Clinical Validation of a portable TIRF microscopy module (SeeTB) for TB diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/11/021915
Enrollment
1000
Registered
2019-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

None listed

Sponsors

Valetude Primus Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult males or females with clinical suspicion of pulmonary tuberculosis including symptoms of cough for more than 2 weeks, weight loss, hemoptysis, mild fever or loss of appetite will be recommended by the physician for the study.

Exclusion criteria

Exclusion criteria: Patients with extrapulmonary tuberculosis, HIV-positive patient and patients unwilling to give consent will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of the novel test w.r.t. GeneXpert and Liquid Culture for tuberculosis diagnosis.Timepoint: The estimated duration of the study is 1 year.

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactAmir Khan

Valetude Primus Healthcare Pvt. Ltd.

vikaspvaletude@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026