Clinical Trial

Robotic Bronchoscopy With CBCT Image Fusion for Pulmonary Nodule Diagnosis in People Living With HIV

Not Yet Recruiting
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Summary
This multicenter study evaluates a full-situational awareness robotic bronchoscopy system combined with CBCT-based multimodal image fusion for diagnosing lung nodules in people living with HIV (PLWH). Lung nodules are small lesions that may be benign or cancerous. In PLWH, accurate diagnosis is especially important but challenging. In this study, participants will be assigned to one of two groups: * Experimental group: Robotic bronchoscopy with real-time full-situational awareness and CBCT image fusion; * Control group: Electromagnetic navigation-guided bronchoscopy combined with radial endobronchial ultrasound (EBUS). In both groups, rapid on-site cytologic evaluation (ROSE) will be performed to confirm tissue adequacy. For participants confirmed to have lung cancer and meeting safety criteria, an exploratory transbronchial cryoablation will be performed during the same procedure. The study aims to compare diagnostic accuracy and safety between the two approaches and to explore the feasibility of immediate cryoablation for early-stage lung cancer in PLWH.
Trial Details
NCT Number NCT07663656
Lead Sponsor wu qingguo
Collaborators: Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Chest Hospital
Conditions HIV Infections, Pulmonary Nodule
Enrollment 100 participants
Start Date 2026-07
Primary Completion 2028-01 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-23