An interventional study of Preoperative navigation path planning using the SARS-pro navigation system and Preoperative navigation path planning using the VBN navigation system in Lung Cancer, Peripheral Pulmonary Nodules, sponsored by Jisong Zhang. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Jisong Zhang · Not applicable, Interventional, and Diagnostic
To verify the clinical effectiveness and safety of the airway tree navigation system constructed by artificial intelligence (AI) in the navigation diagnosis of peripheral pulmonary nodules (PPLs).
Early diagnosis and treatment of lung cancer is of great significance, in which navigated tracheoscopic biopsy is an important tool for confirming the diagnosis of early lung cancer. Conventional navigation software realizes airway reconstruction and guides biopsy by recognizing differences in HU values on computed tomography scans. It is difficult for conventional navigation software to recognize the reconstruction due to the special characteristics of small airways that are susceptible to interference and collapse. Therefore, an AI deep learning approach can realize accurate construction of small airways and guide accurate biopsy. This study intends to validate the clinical effectiveness and safety of the AI-constructed airway tree navigation system in the navigational diagnosis of peripheral pulmonary nodules (PPLs).
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 92 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Jisong Zhang is the lead sponsor of 2 studies on the registry; none are open to participants now.
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The new AI-constructed airway tree navigation system (SARS-pro) was used for preoperative navigation path planning. The SARS-pro navigation system was independently developed by the research group based on a conventional augmented reality optical navigation system (LungPro; Bronchus Company).
Diagnostic Test: Preoperative navigation path planning using the SARS-pro navigation system
Preoperative navigation path planning was performed using the old VBN system (LungPro; Bronchus Company).
Diagnostic Test: Preoperative navigation path planning using the VBN navigation system
The SARS-pro navigation system was used for preoperative navigation path planning for tracheoscopic biopsies in the new navigation system group (patients with suspected lung cancer).
The VBN navigation system was used for preoperative navigation path planning for tracheoscopic biopsies in the old navigation system group (patients with suspected lung cancer).
Diagnostic positive yield
After biopsy by navigational bronchoscopy, the biopsy tissue was tested for lung cancer pathology. A positive diagnosis was defined when the pathology report was a neoplastic lesion (benign or malignant tumor). A positive diagnosis was also made if the pathology report was a granulomatous lesion (with tuberculosis or fungus). If the pathology was reported as an inflammatory cell infiltration or other non-specific inflammation in the lungs, the subject underwent another pathology biopsy after at least 3 months of follow-up to rule out false-positive results due to a change in the site of the lesion.
Time frame: One month after the patients were enrolled
Adverse events
Patients underwent a follow-up period of 3 days after navigational tracheoscopic biopsy, and subjects were followed for adverse events such as hemoptysis, pneumothorax, and mediastinal emphysema.
Time frame: 3 days after navigational tracheoscopic biopsy
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Plan to share: No
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Jisong Zhang