Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Multiple Pulmonary Nodules

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

nCLE aided RANB biopsy procedure using the Monarch® robotic-assisted navigational bronchoscopy platform and Cellvizio® I.V.E. system with AQ-Flex™ 19 Confocal Miniprobe™ used in combination with Fluorescein.

nCLE aided RANB biospy

Balaji Laxmanan, MD

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.

Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

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

The accuracy of the positional relationship between the nCLE needle/probe and the index PPN will be determined using CBCT imaging.

The real-time nCLE imaging assessment of the index PPN for malignancy will be compared to the histopathology biopsy results of the index PPN.

Diagnostic yield for all nCLE aided RANB biopsy performed for the index PPN will be evaluated based on histopathological assessment of acquired tissue samples.

The post-procedure nCLE image assessment of the index PPN for malignancy will be compared to the histopathology biopsy results of the index PPN.

The post-procedure nCLE image assessment of the index PPN will be obtained by multiple independent, blinded raters; the intra- and interobserver agreement will be determined.

The safety of nCLE aided RANB biopsy procedure will be reported as the number and frequency of adverse events (AEs) and procedure-related AEs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy	NCT05231278	Lung Neoplasms	nCLE aided RANB...	22 Years -	Johnson & Johnson Enterprise Innovation Inc.
Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy	NCT05231278	Lung Neoplasms	nCLE aided RANB...	22 Years -	Johnson & Johnson Enterprise Innovation Inc.

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