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Brief Title: Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy
Official Title: Needle-Based Confocal Laser Endomicroscopy to Aid in Lung Nodule Localization by Robotic-Assisted Navigational Bronchoscopy
Study ID: NCT05231278
Brief Summary: 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).
Detailed Description: 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.
Minimum Age: 22 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
John Muir Health, Concord, California, United States
Clinical Research Associates of Central PA, Altoona, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center of the American Oncologic Hospital, Inc., Philadelphia, Pennsylvania, United States
Name: Balaji Laxmanan, MD
Affiliation: Johnson & Johnson Enterprise Innovation Inc.
Role: STUDY_DIRECTOR