The purpose of this study is to determine if the cone beam computed tomography (CBCT)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.
This clinical trial examines the effectiveness of a treatment comparing it to another known treatment. The U.S. Food and Drug Administration (FDA) has approved the navigation bronchoscopy as a treatment option for this disease. The U.S. Food and Drug Administration (FDA) has approved the Cone-Beam CT scan as a treatment option for this disease. This research study involves a screening period, a procedure and follow up visits. The names of the study interventions involved in this study are: * Computed tomography (CBCT)-guided navigation bronchoscopy (CBCT-guided NB) * Navigation bronchoscopy alone Participants will receive the study procedure and will be followed for up to 6 months. It is expected that about 136 people will take part in this research study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.
Per Protocol
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States
Overall Diagnostic Yield
The overall diagnostic yield will be calculated by adding the number of true positives (TP) for both malignancy and benign disease in the numerator and dividing by the total number of procedures performed for each arm of the study. Proportions will be compared with the Chi-Square Test as this test is equivalent to the z-test of two proportions (26). A p-value \<0.05 will be considered as statistically significant.
Time frame: 6 months
Overall Incidence of Procedure-related Complications
To compare complications between navigational bronchoscopy alone and CBCT guided bronchoscopy.
Time frame: 6 months
Additional Diagnostic Procedures in Navigational Bronchoscopy Alone and CBCT Guided Bronchoscopy.
To compare the need of additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy.
Time frame: 6 Months
Navigational Time in Bronchoscopy Alone and CBCT Guided Bronchoscopy.
To compare the navigational time defined as the time between the start of catheter driving after registration until catheter is parked for biopsy.
Time frame: 6 Months
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