Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

Study 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).

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Key things to know

Main goalDevice Feasibility

This describes the study’s primary purpose.

What is being studiednCLE aided RANB biospy

The study team can explain what participation involves.

Who it may be forLung Neoplasms

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 13, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Johnson & Johnson Enterprise Innovation Inc.

Study sponsor

Study overview

What this study is about

Purpose: Device Feasibility
Study type: Interventional
Phase: Not applicable
Sponsor: Johnson & Johnson Enterprise Innovation Inc.
Interventions being studied: Device: nCLE aided RANB biospy

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

John Muir HealthConcord, California
Clinical Research Associates of Central PAAltoona, Pennsylvania
University of PennsylvaniaPhiladelphia, Pennsylvania
Fox Chase Cancer Center of the American Oncologic Hospital, Inc.Philadelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 13, 2026. Always confirm current availability with the study team.

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