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Lung Flute ECO evaluation

Evaluation of the Lung Flute ECO: to assist in sputum production for the detection of tuberculosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202301719591790
Enrollment
10905
Registered
2023-01-30
Start date
2022-07-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Tuberculosis

Interventions

Video instruction for sputum production

Sponsors

Research Institute of Tuberculosis RIT
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Symptoms suggestive of pulmonary TB and/or an abnormal chest X-ray • Able and willing to provide written informed consent (>20 years) or minor assent (12-20) and parental consent for participants 6-20 years. • Able to understand instructions in one of the four commonly used languages (English, French, Fulfulde, Pidgin)

Exclusion criteria

Exclusion criteria: • Contraindicated for sputum induction (Asthma, with acute exacerbation in last two weeks (any attack within the last two weeks); dyspnea or respiratory distress, grade 3 or 4, in the last one week; hypoxemia (SpO2 <90% in ambient air); hemoptysis (coughing up blood), in last one week; history of esophageal operation; known eardrum damage or other middle ear lesions; acute sinusitis, with documentation; nosebleed, in the last one week; nausea, grade 3 or 4, in the last two days; vomiting, grade 3 or 4, in the last two days) • Currently on TB treatment • Inability to sit upright for 20 minutes • Refusal to signed informed consent form or assent form (12-20 years) or parental informed consent form (6-20years). • Other issue raised for exclusion based on the judgement of the clinical and/or study personnel

Design outcomes

Primary

MeasureTime frame
The estimated proportion of people testing positive for TB

Secondary

MeasureTime frame
Sputum quantity (1-2mL, >2-3mL, >3-4mL, >4mL) ;Adverse events or symptom aggravation, with severity grading;Cost per participant tested Cost per TB case diagnosed ;Incremental cost per TB case diagnosed/per participant tested

Countries

Cameroon

Contacts

Public ContactSatoshi Mitarai

Research Institute of Tuberculosis

mitarai@jata.or.jp81424935711

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026