Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis
2 other identifiers
interventional
88
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2019
CompletedFirst Posted
Study publicly available on registry
January 14, 2019
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2022
CompletedApril 20, 2022
April 1, 2022
3.2 years
January 10, 2019
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
detection of M. tuberculosis and resistant-conferring mutations
evaulation by sensitivity, specificity, PPV and NPV
2months after procedure
Secondary Outcomes (1)
time to appropriate treatment and stain/culture conversion
6months after procedure
Study Arms (2)
Conventional arm
NO INTERVENTIONPerform bronchial washing using conventional methods. * CT-guided thick bronchoscope
Investigational arm
ACTIVE COMPARATORPerform bronchial washing using investigational methods. * virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter)
Interventions
targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Hospital
Busan, 49241, South Korea
Related Publications (1)
Eom JS, Park S, Jang H, Kim S, Yoo WH, Kim SH, Mok J. Bronchial Washing Using a Thin Versus a Thick Bronchoscope to Diagnose Pulmonary Tuberculosis: A Randomized Trial. Clin Infect Dis. 2023 Jan 13;76(2):238-244. doi: 10.1093/cid/ciac789.
PMID: 36151949DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeongha Mok, MD, PhD
Pusan National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
January 10, 2019
First Posted
January 14, 2019
Study Start
February 1, 2019
Primary Completion
April 19, 2022
Study Completion
April 19, 2022
Last Updated
April 20, 2022
Record last verified: 2022-04