CompletedNot applicableNCT05231278

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

StatusCompleted
PhaseNot applicable
U.S. locations4
SponsorJohnson & Johnson Enterprise Innovation Inc.
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

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.

04
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.

View original record ↗