Back to resultsThin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis
Primary Purpose
Tuberculosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Thin bronchoscope and VBN
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis
Eligibility 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
Sites / Locations
- Pusan National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Conventional arm
Investigational arm
Arm Description
Perform bronchial washing using conventional methods. CT-guided thick bronchoscope
Perform bronchial washing using investigational methods. virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter)
Outcomes
Primary Outcome Measures
detection of M. tuberculosis and resistant-conferring mutations
evaulation by sensitivity, specificity, PPV and NPV
Secondary Outcome Measures
time to appropriate treatment and stain/culture conversion
date of treatment initiation and stain/culture negative conversion
Full Information
NCT ID
NCT03802812
First Posted
January 10, 2019
Last Updated
April 19, 2022
Sponsor
Pusan National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03802812
Brief Title
Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis
Official Title
Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Rapid Detection of Mycobacterium Tuberculosis and Resistant-conferring Mutations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional arm
Arm Type
No Intervention
Arm Description
Perform bronchial washing using conventional methods.
CT-guided thick bronchoscope
Arm Title
Investigational arm
Arm Type
Active Comparator
Arm Description
Perform bronchial washing using investigational methods.
virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter)
Intervention Type
Device
Intervention Name(s)
Thin bronchoscope and VBN
Intervention Description
targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system
Primary Outcome Measure Information:
Title
detection of M. tuberculosis and resistant-conferring mutations
Description
evaulation by sensitivity, specificity, PPV and NPV
Time Frame
2months after procedure
Secondary Outcome Measure Information:
Title
time to appropriate treatment and stain/culture conversion
Description
date of treatment initiation and stain/culture negative conversion
Time Frame
6months after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeongha Mok, MD, PhD
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis
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