Trial results for a study evaluating a Virtual Navigation (VN) system for bronchoscopic lung nodule sampling in Lung Cancer were posted on ClinicalTrials.gov on 2026-05-15, with 110 participants enrolled.
Background
Lung cancer diagnosis often relies on bronchoscopic evaluation and tissue sampling of suspicious lung nodules and other chest lesions. The accuracy and safety of these procedures can be critical for timely diagnosis and treatment planning. Navigating the complex airway tree to reach peripheral lesions can be challenging, potentially impacting diagnostic yield and procedural efficiency. The Virtual Navigation (VN) system, described as a software package running on a mobile Windows-based computer, aims to assist clinicians by integrating multiple clinical image/video sources, such as 3D CT and PET scans, with bronchoscopic video. This technology seeks to enhance the precision of tissue sampling for lung cancer and other chest lesions.
Trial design
This completed study enrolled 110 participants to evaluate a Virtual Navigation (VN) system for bronchoscopic lung nodule sampling in individuals with Lung Cancer. The trial compared outcomes between a "Historical Controls Cohort" and a "Consented Clinical Bronchoscopy Cohort" utilizing the VN system. The overall goal was to assess the role of the Virtual Navigator system in the bronchoscopic evaluation and tissue sampling of lung cancer and other chest lesions.
Key results
The trial results highlighted several key measurements related to safety, functionality, and procedural metrics:
- Safety Measurement:
- 0 adverse events were reported in the "Historical Controls Cohort - Peripheral Arm".
- 0 adverse events were reported in the "Historical Controls Cohort - Central Arm".
- 0 adverse events were reported in the "Consented Clinical Bronchoscopy Cohort - Peripheral Arm".
- 0 adverse events were reported in the "Consented Clinical Bronchoscopy Cohort - Central Arm".
- Functionality Measurement:
- 0 software malfunctions were reported in the "Consented Clinical Bronchoscopy Cohort - Peripheral Arm".
- 0 software malfunctions were reported in the "Consented Clinical Bronchoscopy Cohort - Central Arm".
- Diagnostic Biopsy Yield:
- The "Historical Controls Cohort - Peripheral Arm" reported 35 adequate biopsies.
- The "Historical Controls Cohort - Central Arm" reported 45 adequate biopsies.
- Radial Endobronchial Ultrasound (EBUS) Probe Passes:
- The "Historical Controls Cohort - Peripheral Arm" had a mean of 7.7 passes per ROI.
- The "Consented Clinical Bronchoscopy Cohort - Peripheral Arm" had a mean of 1 pass per ROI.
- Comparison of the Number of Lymph Nodes and Nodal Stations Visited:
- The "Historical Controls Cohort - Central Arm" had a mean of 2.67 nodes and stations visited per case.
- The "Consented Clinical Bronchoscopy Cohort - Central Arm" had a mean of 5.69 nodes and stations visited per case.
What this means
The posted results indicate that the Virtual Navigation system demonstrated a favorable safety profile, with 0 adverse events reported across all cohorts, and 0 software malfunctions in the cohorts utilizing the system. The data also suggests potential improvements in procedural efficiency and thoroughness. Specifically, the mean number of Radial Endobronchial Ultrasound (EBUS) probe passes per region of interest significantly decreased from 7.7 in historical controls to 1 in the Virtual Navigation cohort for peripheral arm procedures. Furthermore, the mean number of lymph nodes and nodal stations visited per case increased from 2.67 in historical controls to 5.69 in the Virtual Navigation cohort for central arm procedures. These findings suggest that the Virtual Navigation system could enhance the safety and efficiency of bronchoscopic lung nodule sampling, potentially leading to more comprehensive diagnostic evaluations for lung cancer patients.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05599321, titled "Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling", were posted on 2026-05-15 on clinicaltrials.gov.