Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy
United States53 participantsStarted 2022-01-20
Plain-language 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).
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility as Assessed by Proportion of Participants with Accurate 'Tool-in-lesion' Position During Needle-based Confocal Laser Scanning Endomicroscopy (nCLE)-Aided Robotic-Assisted Navigational Bronchoscopy (RANB)
Timeframe: Intra-procedure
Trial details
NCT IDNCT05231278
SponsorJohnson & Johnson Enterprise Innovation Inc.