Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy
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).
Checked against the public recordLast updated May 13, 2026 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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. Exclusion 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.
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.