Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis

April 19, 2022 updated by: Jeongha Mok, Pusan National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional arm

Perform bronchial washing using conventional methods.

  • CT-guided thick bronchoscope
Active Comparator: Investigational arm

Perform bronchial washing using investigational methods.

  • virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter)
Device: Thin bronchoscope and VBN
targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection of M. tuberculosis and resistant-conferring mutations
Time Frame: 2months after procedure
evaulation by sensitivity, specificity, PPV and NPV
2months after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to appropriate treatment and stain/culture conversion
Time Frame: 6months after procedure
date of treatment initiation and stain/culture negative conversion
6months after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: Jeongha Mok, MD, PhD, Pusan National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

April 19, 2022

Study Completion (Actual)

April 19, 2022

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBVBN study
  • 2018R1C1B5085364 (Other Grant/Funding Number: National Research Foundation of Korea)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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