Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

Completed · Not applicable

Conditions studied: Lung Neoplasms

In brief

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).

Key facts

Study ID

NCT05231278

Run by

Johnson & Johnson Enterprise Innovation Inc.

People needed

53

Starts

2022-01-20

Expected to finish

2024-09-06

Last updated by the study team

2026-05-13

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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