NCT05231278Completed
Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy
Needle-Based Confocal Laser Endomicroscopy to Aid in Lung Nodule Localization by Robotic-Assisted Navigational Bronchoscopy
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 53 (actual)
- First submitted
- 28 Jan 2022
- Start date
- 20 Jan 2022
- Primary completion date
- 12 Oct 2023
- Lead sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- Diseases
- Lung cancer
- NCT number
- NCT05231278
What you commit to
- Study type: Interventional
- Participants enrolled: 53
- From 20 Jan 2022 to the primary completion date, 12 Oct 2023
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned surgical resection at the time of bronchoscopy
Lab values
- 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.
- Known hypersensitivity to fluorescein sodium or any other ingredients in the fluorescein product.
Other
- 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.
- 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.
- Female subjects who are pregnant or nursing at the time of the procedure.
Who the study is looking for
- 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.
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Associates of Central PA Coordinator of this site? Confirm its status | Altoona | United States | Unknown status |
| John Muir Health Coordinator of this site? Confirm its status | Concord | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Fox Chase Cancer Center of the American Oncologic Hospital, Inc. Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.