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Completed

NCT Number: NCT03802812

Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis

This study investigates the utility of thin bronchoscope and virtual bronchoscopic navigation system (targeted bronchial washing) for detection of M. tuberculosis and resistant-conferring mutations in patients with pulmonary tuberculosis. Time to appropriate treatment and stain/culture conversion are also evaluated.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Hospital

Busan, 49241, South Korea

About this study

Comparisons of detection rate of M. tuberculosis and resistant-conferring mutations between patients who perform CT-guided conventional bronchoscope and patients who perform VBN-guided thin bronchoscope.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age of 18 or more
  • persons who are suspected with pulmonary tuberculosis on radiologic examination
  • persons who cannot spit sputum or persons with negative results on sputum AFB smear and TB-PCR or Xpert MTB/RIF assay

Exclusion criteria

  • persons who do not agree with bronchoscopy (persons who want empirical treatment for TB)
  • persons with contraindications for bronchoscopy
  • bleeding tendency
  • uncontrolled respiratory disease (hypoxemia)
  • uncontrolled cardiovascular disease

Treatment and study plan

Thin bronchoscope and VBN

Device

targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system

Primary outcomes

  1. detection of M. tuberculosis and resistant-conferring mutations

    Time frame: 2months after procedure

    evaulation by sensitivity, specificity, PPV and NPV

Secondary outcomes

  1. time to appropriate treatment and stain/culture conversion

    Time frame: 6months after procedure

    date of treatment initiation and stain/culture negative conversion

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study title

Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Rapid Detection of Mycobacterium Tuberculosis and Resistant-conferring Mutations

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2019
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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