An interventional study of Virtual bronchoscopy navigation and radial EBUS in Lung Cancer, Tuberculosis and Pneumonia, sponsored by Ilya Sivokozov. Recruiting at 6 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by Ilya Sivokozov · Not applicable, Interventional, and Diagnostic
Peripheral pulmonary lesions are of growing importance in respiratory field. Early detection of lung cancer, tuberculosis and other diseases often needs a bronchoscopic investigation with different types of navigation. Current randomized clinical study is intended to compare three different modalities of navigation in bronchial tree - virtual bronchoscopy (VBN), radial endobronchial ultrasound (EBUS) and combination of both techniques.
Current randomized clinical study is intended to compare three different modalities of navigation in bronchial tree - virtual bronchoscopy, radial EBUS and combination of both techniques. Around 300 patients with incidentally detected peripheral pulmonary lesions will be enrolled in 9 centers among Russia. All patients after obtaining an informed consent will be randomized in 1:1:1 fashion to three study groups depending on type of navigation technique used. All patients will undergone navigational bronchoscopy with rEBUS (group A), VBN (group B) and rEBUS+VBN (group C), data on diagnostic efficacy and safety of each modality of navigation will be analyzed.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →This is the only study on the registry with Ilya Sivokozov as lead sponsor.
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Exclusion Criteria:
Virtual bronchoscopy
Diagnostic Test: Virtual bronchoscopy navigation
Combination of VBN and radial EBUS
Diagnostic Test: Virtual bronchoscopy navigation · Diagnostic Test: radial EBUS
Radial EBUS as a gold standard
Diagnostic Test: radial EBUS
It is planned to use VBN as the only navigation technique to compare it with rEBUS
It is planned to use rEBUS as the only navigation technique to compare it with VBN
Diagnostic Efficacy of navigational bronchoscopy in each study arm
Incidence of final diagnoses confirmed by navigational bronchoscopy for each study arm
Time frame: At the end of study enrollment
Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis
Incidence of final diagnoses confirmed by navigational bronchoscopy for bronchoalveolar lavage, brush and transbronchial lung biopsy separately
Time frame: At the end of study enrollment
Safety profile of each study arm
Incidence of complications reported at each study arm procedures
Time frame: At the end of study enrollment
Plan to share: No
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