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Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis

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ClinicalTrials.gov Identifier: NCT03802812
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jeongha Mok, Pusan National University Hospital

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.

Condition or disease Intervention/treatment Phase
Tuberculosis Device: Thin bronchoscope and VBN Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Rapid Detection of Mycobacterium Tuberculosis and Resistant-conferring Mutations
Estimated Study Start Date : January 20, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

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




Primary Outcome Measures :
  1. detection of M. tuberculosis and resistant-conferring mutations [ Time Frame: 2months after procedure ]
    evaulation by sensitivity, specificity, PPV and NPV


Secondary Outcome Measures :
  1. time to appropriate treatment and stain/culture conversion [ Time Frame: 6months after procedure ]
    date of treatment initiation and stain/culture negative conversion



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802812


Contacts
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Contact: Jeongha Mok, MD, PhD 82512407889 mokgamokga@gmail.com

Locations
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Korea, Republic of
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 49241
Contact: Jeongha Mok, MD    82512407889    mokgamokga@gmail.com   
Sponsors and Collaborators
Pusan National University Hospital
Investigators
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Principal Investigator: Jeongha Mok, MD, PhD Pusan National University Hospital

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Responsible Party: Jeongha Mok, Clinical Professor, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT03802812     History of Changes
Other Study ID Numbers: TBVBN study
2018R1C1B5085364 ( Other Grant/Funding Number: National Research Foundation of Korea )
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections