TuberculosisNCT03802812
Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis
A study testing Thin bronchoscope and VBN in people with Tuberculosis, run by Pusan National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Thin bronchoscope and VBN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2019to 19 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- Thin bronchoscope and VBN
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thin bronchoscope and VBNDevice
targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system
| Study group | Role | What they receive |
|---|---|---|
| Conventional arm | No intervention | Perform bronchial washing using conventional methods. * CT-guided thick bronchoscope |
| Investigational arm | Active comparator | Perform bronchial washing using investigational methods.
* virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter) Receives: Device: Thin bronchoscope and VBN |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of M. tuberculosis and resistant-conferring mutations
evaulation by sensitivity, specificity, PPV and NPV
Measured: 2months after procedure
Secondary outcomes (1)
time to appropriate treatment and stain/culture conversion
date of treatment initiation and stain/culture negative conversion
Measured: 6months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Feb 2019
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeongha Mok, Pusan National University Hospital
- Investigators
- Jeongha Mok, MD, PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802812
- Sponsor's protocol ID
- TBVBN study
- Other IDs
- 2018R1C1B5085364
- Status last verified
- Apr 2022
- First submitted
- 10 Jan 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36151949
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Rapid Detection of Mycobacterium Tuberculosis and Resistant-conferring Mutations
- ClinicalTrials.gov ID
- NCT03802812
- Acronym / sponsor ID
- TBVBN study
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional arm | No intervention | –Perform bronchial washing using conventional methods. * CT-guided thick bronchoscope |
| Investigational arm | Active comparator | Device: Thin bronchoscope and VBNPerform bronchial washing using investigational methods. * virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- persons who do not agree with bronchoscopy (persons who want empirical treatment for TB)
- persons with contraindications for bronchoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thin bronchoscope and VBNtargeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system | Device | Investigational arm |
Primary outcome
detection of M. tuberculosis and resistant-conferring mutations
Time frame: 2months after procedure
evaulation by sensitivity, specificity, PPV and NPV
1 secondary outcome
time to appropriate treatment and stain/culture conversion
Time frame: 6months after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 36151949Eom 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeongha Mok, MD, PhD principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thin bronchoscope and VBN in people with Tuberculosis, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of M. tuberculosis and resistant-conferring mutations (time frame: 2months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03802812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.