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NCT03802812 Clinical Trial

Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03802812
Other study ID # TBVBN study
Secondary ID 2018R1C1B5085364
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date April 19, 2022

Study information
Verified date April 2022
Source Pusan National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date April 19, 2022
Est. primary completion date April 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Thin bronchoscope and VBN
targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system

Locations
Country Name City State
Korea, Republic of Pusan National University Hospital Busan

Sponsors (1)
Lead Sponsor Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary detection of M. tuberculosis and resistant-conferring mutations evaulation by sensitivity, specificity, PPV and NPV 2months after procedure
Secondary time to appropriate treatment and stain/culture conversion date of treatment initiation and stain/culture negative conversion 6months after procedure
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