Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

Needle-Based Confocal Laser Endomicroscopy to Aid in Lung Nodule Localization by Robotic-Assisted Navigational Bronchoscopy

This study is designed to evaluate the safety and feasibility of real-time needle-based confocal laser endomicroscopy (nCLE) in improving diagnostic accuracy of robotic-assisted bronchoscopy (RANB) biopsy performed with the Monarch® Endoscopy Platform in patients with peripheral pulmonary nodules (PPN).

Robotic-assisted navigational bronchoscopy (RANB) improves accuracy of lesion localization and diagnostic yield of the peripheral pulmonary nodule (PPN) biopsy compared to conventional flexible bronchoscopy. Needle based confocal laser endomicroscopy (nCLE) allows real-time microstructural imaging of lung nodule tissues at the needle tip. The study is designed to evaluate the safety and feasibility of utilizing nCLE during RANB biopsy procedure to optimize needle position and diagnostic accuracy, as well as reduce or replace the need for additional imaging tools such as radial endobronchial ultrasound (r-EBUS), cone beam computed tomography (CBCT), and/or fluoroscopy during RANB biopsy.

Inclusion Criteria:

• Age ≥ 22 years at signing of informed consent form (ICF).
• Undergoing standard-of-care RANB for a solid lung nodule, which is considered to be at intermediate- to high-risk for malignancy as determined by the investigator per the institution's standard of care.
• ICF signed before any study procedures are initiated.

Exclusion Criteria:

• Medical contraindication to bronchoscopy under general anesthesia, or lack of physical fitness to undergo bronchoscopy under general anesthesia or to follow the study processes, as assessed by the investigator.
• Presence of uncorrectable bleeding disorders, or anticoagulation/anti-platelet aggregation therapy that cannot be withheld for an appropriate interval prior to the procedure, as defined per the institution's standard of care.
• Medical devices interfering with electro-magnetic navigation, including but not limited to pacemakers.
• Subjects who have a target lesion that shows endobronchial involvement on chest CT.
• Participation in any other clinical trial within 30 days of enrollment, that would interfere with this study.
• Known hypersensitivity to fluorescein sodium or any other ingredients in the fluorescein product.
• Planned surgical resection at the time of bronchoscopy
• Female subjects who are pregnant or nursing at the time of the procedure.