Clinical trial · Interventional
LungVision AI-Augmented Fluoroscopic Navigation for Intraoperative Pulmonary Nodule Localization
Clinical Feasibility, Localization Accuracy, and Safety of the LungVision System for Intraoperative Localization of Small Pulmonary Nodules During Thoracoscopic Surgery: A Prospective Single-Center Pilot Study
- 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 prospective single-center pilot study evaluates the clinical feasibility, localization accuracy, and safety of the LungVision system-an AI-augmented fluoroscopic navigation platform-for real-time intraoperative localization of small pulmonary nodules during video-assisted thoracoscopic surgery (VATS). All enrolled patients underwent dual localization: preoperative marking via CT-guided dye injection or virtual bronchoscopic navigation (Broncus Archimedes), followed by intraoperative localization using the LungVision system. The primary outcome was localization success rate, defined as the proportion of patients achieving fluoroscopic tool-in-lesion confirmation. Secondary outcomes included complete resection rate, navigation time, total operative time, and perioperative complication rate.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pulmonary Nodule, Solitary | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LungVision System | Device | — | UNRESOLVED |
| Preoperative Dual Localization | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LungVision AI-Augmented Fluoroscopic Navigation
- description
- Patients underwent intraoperative pulmonary nodule localization using the LungVision system (Body Vision Medical, Israel), an AI-augmented fluoroscopic bronchoscopic navigation platform that integrates preoperative CT imaging with real-time C-arm fluoroscopy via machine learning-based image fusion. Under bronchoscopic guidance, the navigational tool was advanced toward the target lesion, and tool-in-lesion confirmation was verified under fluoroscopic overlay. Upon successful localization, indocyanine green (ICG) dye was injected transbronchially to mark the target nodule. All patients additionally received preoperative localization via CT-guided percutaneous dye injection or virtual bronchoscopic navigation (Broncus Archimedes Software System) as part of the dual-localization protocol. Subsequent video-assisted thoracoscopic surgery (VATS) was performed based on the combined localization findings.
- interventionNames
- Device: LungVision System
- Device: Preoperative Dual Localization
Primary outcomes (1)
- measure
- Localization Success Rate
- timeFrame
- Intraoperative
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-65 years * Scheduled to undergo thoracoscopic resection for solitary, subsolid, or ground-glass pulmonary nodules requiring localization * Lesion characteristics and CT imaging indicating need for preoperative localization, as determined by the attending surgeon * Able and willing to complete the study protocol * Able to provide written informed consent Exclusion Criteria: * Age \>65 years * Pregnancy * Bleeding tendency or current use of anticoagulants * Impaired consciousness or inability to communicate * Cognitive impairment precluding autonomous consent
References
Publications (0)
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