Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis

NCT ID: NCT03802812

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-04-19

Brief Summary

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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

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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

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Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Conventional arm

Perform bronchial washing using conventional methods.

* CT-guided thick bronchoscope

Group Type NO_INTERVENTION

No interventions assigned to this group

Investigational arm

Perform bronchial washing using investigational methods.

* virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter)

Group Type ACTIVE_COMPARATOR

Thin bronchoscope and VBN

Intervention Type DEVICE

targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system

Interventions

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Thin bronchoscope and VBN

targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeongha Mok

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeongha Mok, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Hospital

Locations

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Pusan National University Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 36151949 (View on PubMed)

Other Identifiers

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2018R1C1B5085364

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TBVBN study

Identifier Type: -

Identifier Source: org_study_id

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