Clinical trial · Interventional
Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy
Needle-Based Confocal Laser Endomicroscopy to Aid in Lung Nodule Localization by Robotic-Assisted Navigational Bronchoscopy
NCT05231278CI-TRIAL-00111368CLEARcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nCLE aided RANB biospy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nCLE aided RANB biopsy
- description
- Single arm study
- interventionNames
- Device: nCLE aided RANB biospy
Primary outcomes (1)
- measure
- 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
- description
- Cone-beam computed tomography (CBCT) is used to determine the accuracy of the 'tool-in-lesion' position as obtained during nCLE-aided bronchoscopy.
Secondary outcomes (5)
- measure
- Sensitivity of the real-time nCLE imaging assessment for malignancy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.