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Spots Global Cancer Trial Database for Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

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Trial Identification

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

Conditions

Lung Neoplasms

Study Description

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.

Eligibility

Minimum Age: 22 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Balaji Laxmanan, MD

Affiliation: Johnson & Johnson Enterprise Innovation Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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