The LUCENT Study - LUng Lesion Assessment Via BF-UCP190F for Central and Extended Nodal Targeting

Inclusion criteria

• Willing and able to provide informed consent.
• ≥18 years of age.
• The target lesion(s) must be located within the inner and middle two-thirds of the lung, as determined prospectively using the Software-Assisted Method (SAM). To ensure accurate localization, SAM applies anatomical measurements to classify lesions as inner, middle, or outer third of the lung. The lesion must contact the border of the inner two-thirds region; lesions fully outside this region will be excluded from the study cohort. In addition, the lesion must be located at least two airway generations distal to the main carina, as confirmed radiographically by the bronchoscopist
• Target lesion: nodule ≥ 10mm or lymph node ≥ 5mm.
• Target lesion location documented on CT or PET report.
• Indicated for bronchoscopy.
• Bronchoscopic procedure scheduled within 30 days of the CT or PET report.
• Patient qualifies for a procedure using the BF-UCP190F bronchoscope and the ViziShot 2 25 needle based upon the approved indications for use for those devices.

Exclusion criteria

• Concurrently participating in another competing clinical study.
• Unwilling or unable to return for follow-up, e.g., plans for relocation, unsuitable transportation.
• Patient not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure.
• Currently on anticoagulation that cannot be paused, or a coagulation disorder that, in the opinion of the investigator, would pose an increased risk of bleeding.
• Intraprocedural identification of intrinsic and endoscopically visualized endobronchial lesion for which adequate biopsy can be obtained via endobronchial biopsy.